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In-vitro multiplex assay used with the Biocode MDx 3000 for the detection of respiratory pathogens.
APPLIED BIOCODE, INC.
01
In Commercial Distribution
- 00851034007073 ()
63-R0001
- Multiple-type respiratory pathogen nucleic acid IVD, control
In-vitro multiplex assay used with the Biocode MDx 3000 for the detection of gastrointestinal pathogens.
APPLIED BIOCODE, INC.
1
In Commercial Distribution
- 00851034007011 ()
- Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
S8377 Cleaning MET II Solution membrane bottle , 6*100mL for ABL8XX
Radiometer Medical ApS
944-136
In Commercial Distribution
- 15700699441369 ()
- 05700699441362 ()
944-136
- Wash/cleaning solution IVD, automated/semi-automated system
S1827 Crea Calibration Solution 1, membrane bottle, 6x175 mL, for ABL8XX, USA
Radiometer Medical ApS
944-135
In Commercial Distribution
- 15700699441352 ()
- 05700699441355 ()
944-135
- Multiple blood gas analyte IVD, calibrator
S1837 Crea Calibration Solution 2, membrane bottle, 6x140 mL, for ABL8XX
Radiometer Medical ApS
944-134
In Commercial Distribution
- 15700699441345 ()
- 05700699441348 ()
944-134
- Multiple blood gas analyte IVD, calibrator
S1827 Crea Calibration Solution 1, membrane bottle, 6x175 mL, for ABL8XX, JAP/ROW
Radiometer Medical ApS
944-133
In Commercial Distribution
- 15700699441338 ()
- 05700699441331 ()
944-133
- Multiple blood gas analyte IVD, calibrator
S7375 Cleaning Solution 175mL for ABL7XX
Radiometer Medical ApS
944-123
Not in Commercial Distribution
- 05700699441232 ()
944-123
- Wash/cleaning solution IVD, automated/semi-automated system
S7865 AutoCheck 6+, level 4 box of 30 ampoules, for ABL8XX
Radiometer Medical ApS
944-097
In Commercial Distribution
- 55700699440971 ()
- 05700699440976 ()
944-097
- Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
S7855 AutoCheck 6+, level 3 box of 30 ampoules, for ABL8XX
Radiometer Medical ApS
944-096
In Commercial Distribution
- 55700699440964 ()
- 05700699440969 ()
944-096
- Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
S7845 AutoCheck 6+, level 2 box of 30 ampoules, for ABL8XX
Radiometer Medical ApS
944-095
In Commercial Distribution
- 55700699440957 ()
- 05700699440952 ()
944-095
- Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
S7835 AutoCheck 6+, level 1 box of 30 ampoules, for ABL8XX
Radiometer Medical ApS
944-094
In Commercial Distribution
- 55700699440940 ()
- 05700699440945 ()
944-094
- Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
D8088+D8089 Crea membrane box A+B, with 2xA and 2xB membrane units, for ABL8XX
Radiometer Medical ApS
942-073
In Commercial Distribution
- 05700699420732 ()
942-073
- Creatinine IVD, reagent
D7077 Lac membrane box (4 units) for ABL7XX/8XX
Radiometer Medical ApS
942-066
In Commercial Distribution
- 05700699420664 ()
- 55700699420669 ()
942-066
- Lactate electrode IVD
Dental Whitening Agent
Cavex Holland B.V.
BW090
In Commercial Distribution
- E241BW0900 ()
- 1 pcs
BW090
- Dental bleaching agent
Dental Whitening Agent
Cavex Holland B.V.
BW035
In Commercial Distribution
- E241BW0350 ()
- 1 pcs
BW035
- Dental bleaching agent
Dental Whitening Agent
Cavex Holland B.V.
BW030
In Commercial Distribution
- E241BW0300 ()
- 1 pcs
BW030
- Dental bleaching agent
Dental Whitening Agent
Cavex Holland B.V.
BW015
In Commercial Distribution
- E241BW0150 ()
- 1 pcs
BW015
- Dental bleaching agent
Dental Whitening Agent
Cavex Holland B.V.
BW010
In Commercial Distribution
- E241BW0100 ()
- 1 pcs
BW010
- Dental bleaching agent
Dental Whitening Agent
Cavex Holland B.V.
BW000
In Commercial Distribution
- E241BW0000 ()
- 1 pcs
BW000
- Dental bleaching agent
A ZOICX Additive Sterile Filtered
Incell Corporation, LLC
ZDAN04
In Commercial Distribution
- G507ZDAN040 ()
ZDAN04
- Cell culture medium IVD
Product Description
DSQ Alert® HT HAV Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences within the 5’ UTR of HAV. The mix consists of a total of 7.8 nmol of DSQ probe per vial in a 1X TE buffer solution and must match the expected purity and MW for each oligonucleotide. The probe is labeled with the AP530 fluorophore and has an excitation wavelength maximum of 530 nm and an emission wavelength maximum of 550 nm. Each product lot will go through functional testing with an approved test method.
Storage and Handling Requirements
The reagent contained in this package should be protected from light and stored at less than -10°C. The reagent must be used by the expiration date printed on the vial label. Product use is limited to five freeze-thaw cycles.
Elitechgroup Mdx LLC
M800816
In Commercial Distribution
- 03661540952890 ()
M800816
- Hepatitis A virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Product Description
DSQ Alert® HT HAV Primer Mix is an analyte specific reagent that contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences within the 5’ UTR of HAV. The mix consists of a total of 23.4 nmol of primers per vial in a 1X TE buffer solution and must match the expected purity and MW for each oligonucleotide. The primers target a 90 bp region of the 5’ UTR of HAV. Each product lot will go through functional testing with an approved test method.
Storage and Handling Requirements
The reagent contained in this package shall be shipped on dry ice, be protected from light and stored at less than -10°C. The reagent must be used by the expiration date printed on the vial label. Product use is limited to five freeze-thaw cycles.
Elitechgroup Mdx LLC
M800815
In Commercial Distribution
- 03661540952883 ()
M800815
- Hepatitis A virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Product Description
DSQ Alert® HT Norovirus GII Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences in RNA-dependent RNA polymerase (RdRp) region of Noro virus Genogroup GII. The mix consists of a total of 8.3 nmol of DSQ probe per vial in a 1X TE buffer solution and must match the expected purity and MW for each oligonucleotide. The probe is labeled with the FAM fluorophore and has an excitation wavelength maximum of 496 nm and an emission wavelength maximum of 517 nm. Each product lot will go through functional testing with an approved test method.
Storage and Handling Requirements
The reagent contained in this package should be protected from light and stored at less than -10°C. The reagent must be used by the expiration date printed on the vial label. Product use is limited to five freeze-thaw cycles.
Elitechgroup Mdx LLC
M800822
In Commercial Distribution
- 03661540952876 ()
M800822
- Norovirus nucleic acid IVD, kit, nucleic acid technique (NAT)
Product Description
DSQ Alert® HT Norovirus GII Primer Mix is an analyte specific reagent that contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences in RNA-dependent RNA polymerase (RdRp) region of Norovirus Genogroup GII. The mix consists of a total of 41.6 nmol of primers per vial in a 1X TE buffer solution and must match the expected purity and MW for each oligonucleotide. The primers target a 92 bp amplicon of the RNA-dependent RNA polymerase (RdRp) region of Norovirus Genogroup GII. Each product lot will go through functional testing with an approved test method.
Storage and Handling Requirements
The reagent contained in this package shall be shipped on dry ice, be protected from light and stored at less than -10°C. The reagent must be used by the expiration date printed on the vial label. Product use is limited to five freeze-thaw cycles.
Elitechgroup Mdx LLC
M800821
In Commercial Distribution
- 03661540952869 ()
M800821
- Norovirus nucleic acid IVD, kit, nucleic acid technique (NAT)
Product Description
DSQ Alert® HT Norovirus GI Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences in RNA-dependent RNA polymerase (RdRp) region of Norovirus Genogroup GI. The mix consists of a total of 8.3 nmol of DSQ probe per vial in a 1X TE buffer solution and must match the expected purity and MW for each oligonucleotide. The probe is labeled with the AP593 fluorophore and has an excitation wavelength maximum of 593 nm and an emission wavelength maximum of 613 nm. Each product lot will go through functional testing with an approved test method.
Storage and Handling Requirements
The reagent contained in this package should be protected from light and stored at less than -10°C. The reagent must be used by the expiration date printed on the vial label. Product use is limited to five freeze-thaw cycles.
Elitechgroup Mdx LLC
M800820
In Commercial Distribution
- 03661540952852 ()
M800820
- Norovirus nucleic acid IVD, kit, nucleic acid technique (NAT)
Product Description
DSQ Alert® HT Norovirus GI Primer Mix is an analyte specific reagent that contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences in RNA-dependent RNA polymerase (RdRp) region of Norovirus Genogroup GI. The mix consists of a total of 41.6 nmol of primers per vial in a 1X TE buffer solution and must match the expected purity and MW for each oligonucleotide. The primers target a 92 bp amplicon of the RNA-dependent RNA polymerase (RdRp) region of Norovirus Genogroup GI. Each product lot will go through functional testing with an approved test method.
Storage and Handling Requirements
The reagent contained in this package shall be shipped on dry ice, be protected from light and stored at less than -10°C. The reagent must be used by the expiration date printed on the vial label. Product use is limited to five freeze-thaw cycles.
Warnings and Precautions
Carefully read
Elitechgroup Mdx LLC
M800819
In Commercial Distribution
- 03661540952845 ()
M800819
- Norovirus nucleic acid IVD, kit, nucleic acid technique (NAT)
Product Description
DSQ Alert® HT JCV Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences within the gene A in large tumor antigen region of JC Virus (Human polyomavirus 2). The mix consists of a total of 3.9 nmol of DSQ probe per vial in a 1X TE buffer solution and must match the expected purity and MW for each oligonucleotide. The probe is labeled with the AP530 fluorophore and has an excitation wavelength maximum of 530 nm and an emission wavelength maximum of 550 nm. Each product lot will go through functional testing with an approved test method.
Storage and Handling Requirements
The reagent contained in this package should be protected from light and stored at less than -10°C. The reagent must be used by the expiration date printed on the vial label. Product use is limited to five freeze-thaw cycles.
Elitechgroup Mdx LLC
M800814
In Commercial Distribution
- 03661540952838 ()
M800814
- JC virus (JCV) nucleic acid IVD, kit, nucleic acid technique (NAT)
DSQ Alert® HT JCV Primer Mix is an analyte specific reagent that contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences within the gene A in large tumor antigen region of JC Virus (Human polyomavirus 2). The mix consists of a total of 39.2 nmol of primers per vial in a 1X TE buffer solution and must match the expected purity and MW for each oligonucleotide. The primers target a 78 bp region of the gene A of JCV. Each product lot will go through functional testing with an approved test method.
The reagent contained in this package shall be shipped on dry ice, be protected from light and stored at less than -10°C. The reagent must be used by the expiration date printed on the vial label. Product use is limited to five freeze-thaw cycles
Elitechgroup Mdx LLC
M800813
In Commercial Distribution
- 03661540952821 ()
M800813
- JC virus (JCV) nucleic acid IVD, kit, nucleic acid technique (NAT)
DSQ Alert™ HT HDV Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences within the Hepatitis Delta Virus RNA. The mix consists of a total of 7.8 nmol of DSQ probe per vial in a 1X TE buffer solution. The probe is labeled with the 6-FAM fluorophore and has an excitation wavelength maximum of 496 nm and an emission wavelength maximum of 517 nm.
The reagent contained in this package should be protected from light and stored at less or equal to -10 degrees Celsius. The reagent must be used by the expiration date printed on the vial label. Product use is limited to five freeze-thaws.
Elitechgroup Mdx LLC
M800812
In Commercial Distribution
- 03661540952814 ()
M800812
- Hepatitis D virus nucleic acid IVD, kit, nucleic acid technique (NAT)
DSQ Alert™ HT HDV Primer Mix is an analyte specific reagent that contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences within the Hepatitis Delta Virus RNA. The mix consists of a total of 31.2 nmol of primers per vial in a 1X TE buffer solution. The primers target a 57 bp region of the Hepatitis Delta Virus RNA.
The reagent contained in this package should be protected from light and stored at less or equal to -10 degrees Celsius. The reagent must be used by the expiration date printed on the vial label. Product use is limited to five freeze-thaws.
Elitechgroup Mdx LLC
M800811
In Commercial Distribution
- 03661540952807 ()
m800811
- Hepatitis D virus nucleic acid IVD, kit, nucleic acid technique (NAT)
The DSQ Alert Internal Control Set IC1 contains the MGB Alert IC1 DNA Template, the DSQ Alert IC1 v3.0 Primers, and the DSQ Alert
IC1 Probe. When used as intended, the Internal Control Set IC1 DSQ will detect systemic variation that may arise during the nucleic acid
extraction and amplification processes associated with real-time PCR assays.
The reagent contained in this package should be protected from light and stored at less or equal to -10 degrees Celsius. The reagent must be used by the expiration date printed on the vial label. Product use is limited to five freeze-thaws.
Elitechgroup Mdx LLC
M800734
In Commercial Distribution
- 03661540952791 ()
M800734
- Nucleic acid amplification primer IVD
DSQ Alert® BK Virus ASR v3.0 Probe Mix contains chemically synthesized DNA oligonucleotides designed to detect nucleic acids from the BK
Virus.
Elitechgroup Mdx LLC
M800733
In Commercial Distribution
- 03661540952784 ()
- Nucleic acid amplification primer IVD
The DSQ Alert Internal Control Set IC1 contains the MGB Alert IC1 DNA Template, the DSQ Alert IC1 v3.0 Primers, and the MGB Alert
IC1 Probe. When used as intended, the Internal Control Set IC1 DSQ will detect systemic variation that may arise during the nucleic acid
extraction and amplification processes associated with real-time PCR assays.
Elitechgroup Mdx LLC
M800728
In Commercial Distribution
- 03661540952760 ()
- Nucleic acid amplification primer IVD
DSQ Alert® BK Virus ASR v3.0 Probe Mix contains chemically synthesized DNA oligonucleotides designed to detect nucleic acids from the BK Virus. The mix consists of a total of 0.64 nmol of DSQ probe per vial in a 1X TE buffer solution. The probe is specific to a region of the major capsid protein VP1 gene of the BK Virus.
The reagent contained in this package should be protected from light and stored at less than -10°C. The reagent must be used by the expiration date printed on the vial label. Product use is limited to five freeze-thaw cycles.
Elitechgroup Mdx LLC
M800727
In Commercial Distribution
- 03661540952753 ()
- BK virus (BKV) nucleic acid IVD, kit, nucleic acid technique (NAT)
DSQ Alert Parechovirus v2.0 Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences within the 5’-untranslated region (5’-UTR) of the parechovirus RNA genome. The mix consists of a total of 0.8 nmol of DSQ probe per vial in a 1X TE buffer solution. The probe is labeled with the AP593 fluorophore and has an excitation wavelength maximum of 593 nm and an emission wavelength maximum of 613 nm.
Elitechgroup Mdx LLC
M800759
In Commercial Distribution
- 03661540952708 ()
M800759
- Human parechovirus (HPeV) nucleic acid IVD, reagent
DSQ Alert Parechovirus v2.0 Primer Mix is an analyte specific reagent that contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences within the 5’ untranslated region (5’-UTR) of the parechovirus RNA genome. The mix consists of a total of 6.0 nmol of primers per vial in a 1X TE buffer solution. The primers target a 130 bp region of the 5’-UTR of parechovirus.
Elitechgroup Mdx LLC
M800758
In Commercial Distribution
- 03661540952692 ()
M800758
- Human parechovirus (HPeV) nucleic acid IVD, reagent
DSQ Alert™ HT Candida auris Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences within the ITS2 gene of Candida auris. The mix consists of a total of 3.9 nmol of probe per vial in a 1X TE buffer solution. The probe is labeled with FAM and has an excitation wavelength maxima of 496 nm and an emission wavelength maxima of 517 nm.
Elitechgroup Mdx LLC
M800761
In Commercial Distribution
- 03661540952579 ()
- Candida auris nucleic acid IVD, kit, nucleic acid technique (NAT)
DSQ Alert™ HT Candida auris Primer Mix is an analyte specific reagent that contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences within the ITS2 gene of Candida auris. The mix consists of a total of 39.2 nmol of primers per vial in a 1X TE buffer solution. The primers target a 124 bp region of the ITS2 gene of Candida auris.
Elitechgroup Mdx LLC
M800760
In Commercial Distribution
- 03661540952562 ()
M800760
- Candida auris nucleic acid IVD, kit, nucleic acid technique (NAT)
The DSQ Alert IC2 Probe Mix contains a chemically synthesized DNA oligonucleotide probe designed to detect the IC2 nucleic acid sequence
Elitechgroup Mdx LLC
800741
In Commercial Distribution
- 03661540952555 ()
800741
- Exogenous DNA/RNA internal control IVD, kit
DSQ Alert™ Candida auris Probe Mix ASR is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences within the ITS2 of Candida auris.
Elitechgroup Mdx LLC
800730
In Commercial Distribution
- 03661540952548 ()
800730
- Assay development analyte-specific reagent IVD
DSQ Alert™ Candida auris Primer Mix ASR is an analyte specific reagent that contains chemically synthesized DNA oligonucleotides designed to amplify an 125 bp region within the ITS2 gene of Candida auris. The mix consists of a single vial containing a set of primers in a 1X TE buffer solution.
Elitechgroup Mdx LLC
800729
In Commercial Distribution
- 03661540952531 ()
800729
- Assay development analyte-specific reagent IVD
The MGB Alert ELITaq Master Mix is a premixed ready-to-use solution containing necessary components and reaction buffer for efficient amplification of DNA templates by PCR. The solution is supplied at 2X relative to the optimal final concentration in the PCR, and contains 2X reaction buffer, dNTPs, MgCl2, and DNA polymerase with 5’ - 3’ exonuclease activity. PCR grade water is also provided in the product.
Elitechgroup Mdx LLC
M800810
In Commercial Distribution
- 03661540952524 ()
M800810
- Nucleic acid amplification mastermix kit IVD
The MGB Alert ELITaq Master Mix is a premixed ready-to-use solution containing necessary components and reaction buffer for efficient amplification of DNA templates by PCR. The solution is supplied at 2X relative to the optimal final concentration in the PCR, and contains 2X reaction buffer, dNTPs, MgCl2, and DNA polymerase with 5’ - 3’ exonuclease activity. PCR grade water is also provided in the product.
Elitechgroup Mdx LLC
M800809
In Commercial Distribution
- 03661540952517 ()
M800809
- Nucleic acid amplification mastermix kit IVD
The MGB Alert Internal Control MS2 RNA Template consists of an RNA bacteriophage intended for use as an internal extraction and amplification process control in any real-time polymerase chain reaction (PCR) assay. The MS2 Internal Control can be used to detect systemic variation that may arise during the extraction and amplification process associated with real-time PCR assays. The internal control is not intended to monitor other real-time PCR processes.
Elitechgroup Mdx LLC
M800740
In Commercial Distribution
- 03661540952425 ()
- Nucleic acid amplification primer IVD
The MGB Alert Internal Control MS2 DNA Template consists of a DNA plasmid intended for use as an unassayed internal extraction and amplification process control in any real-time polymerase chain reaction (PCR) assay. The MS2 Internal Control can be used to detect systemic variation that may arise during the extraction and amplification process associated with real-time PCR assays. The internal control is not intended to monitor other real-time PCR processes.
Elitechgroup Mdx LLC
M800739
In Commercial Distribution
- 03661540952418 ()
- Nucleic acid amplification primer IVD
The MGB Alert Internal Control IC2 Template consists of a DNA plasmid intended for use as an unassayed internal extraction and amplification process control in any real-time polymerase chain reaction (PCR) assay. The IC2 Internal Control can be used to detect systemic variation that may arise during the extraction and amplification process associated with real-time PCR assays. The internal control is not intended to monitor other real-time PCR processes.
Elitechgroup Mdx LLC
M800738
In Commercial Distribution
- 03661540952401 ()
- Nucleic acid amplification primer IVD
The MGB Alert Internal Control IC2 Template consists of a DNA plasmid intended for use as an unassayed internal extraction and amplification process control in any real-time polymerase chain reaction (PCR) assay. The IC2 Internal Control can be used to detect systemic variation that may arise during the extraction and amplification process associated with real-time PCR assays. The internal control is not intended to monitor other real-time PCR processes.
Elitechgroup Mdx LLC
M800737
In Commercial Distribution
- 03661540952395 ()
- Nucleic acid amplification primer IVD
The MGB Alert Internal Control IC1 Template consists of a DNA plasmid intended for use as an unassayed internal extraction and amplification process control in any real-time polymerase chain reaction (PCR) assay. The IC1 Internal Control can be used to detect systemic variation that may arise during the extraction and amplification process associated with real-time PCR assays. The internal control is not intended to monitor other real-time PCR processes.
Elitechgroup Mdx LLC
M800736
In Commercial Distribution
- 03661540952388 ()
M800736
- Nucleic acid amplification primer IVD
MGB Alert® Trichomonas vaginalis Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from
Trichomonas vaginalis. The mix consists of a total of 3.5 nmol of primers per vial in a 1X TE buffer solution. The primers amplify a 67 bp nucleic acid
sequence from a repeated DNA fragment in Trichomonas vaginalis.
Elitechgroup Mdx LLC
M800583-am
In Commercial Distribution
- 03661540950230 ()
M800583-am
- Trichomonas vaginalis nucleic acid IVD, kit, nucleic acid technique (NAT)
"MGB Alert® Trichomonas vaginalis Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from
Trichomonas vaginalis. The mix consists of a total of 3.5 nmol of primers per vial in a 1X TE buffer solution. The primers amplify a 67 bp nucleic acid
sequence from a repeated DNA fragment in Trichomonas vaginalis."
Elitechgroup Mdx LLC
M800583
In Commercial Distribution
- 03661540950223 ()
M800583
- Trichomonas vaginalis nucleic acid IVD, kit, nucleic acid technique (NAT)