Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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ORTHODONTIC GLITTER
LANG DENTAL MANUFACTURING CO., INC.
28 GRAMS SILVER BLACK MIX
In Commercial Distribution

  • D6502410SB0 ()
2410SB

  • Dental prosthesis restorative material, unfilled resin
ORTHODONTIC GLITTER
LANG DENTAL MANUFACTURING CO., INC.
28 GRAMS BLUE GREEN MIX
In Commercial Distribution

  • D6502410BG0 ()
2410BG

  • Dental prosthesis restorative material, unfilled resin
3 Montage Flowable Static Mix Tips to be used in conjunction with: 1 Montage Flowable Cartridge 00850391007290 and 1 Montage Flowable Dispenser 00850391007306
ABYRX, INC.
MON-BVF-1501FL
In Commercial Distribution

  • 00850391007313 ()


  • Orthopaedic cement dispenser
MGB 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

  • 03661540952326 ()


  • Nucleic acid amplification primer IVD
MGB Alert® BK Virus ASR v3.0 Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acids from the BK Virus.
Elitechgroup Mdx LLC
M800732
In Commercial Distribution

  • 03661540952319 ()


  • 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
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Jar. 9 gram Light Gel Etch Bottle. Spanish, Boxed.
SCIENTIFIC PHARMACEUTICALS, INC.
SP 65-023 SB
In Commercial Distribution

  • D801SP65023SB1 ()
65-023

  • Dentine adhesive
MGB Alert® Adenovirus Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from Adenovirus. The mix consists of a total of 3.3 nmol of primers per vial in a 1X TE buffer solution. The primers amplify the hexon gene, which covers all known Adenovirus types.
Elitechgroup Mdx LLC
800497
In Commercial Distribution

  • 03661540951664 ()
800497

  • Adenovirus nucleic acid IVD, kit, nucleic acid technique (NAT)
"MGB Alert® VZV Primer Mix contains chemically synthesized DNA oligonucleotides designed to amplify nucleic acid sequences from VZV (VaricellaZoster Virus). The mix consists of a total of 3.5 nmol of primers per vial in a 1X TE buffer solution. The primers amplify the VZV sequence within the ORF 38 region."
Elitechgroup Mdx LLC
800418
In Commercial Distribution

  • 03661540951510 ()
800418

  • Varicella-zoster virus (VZV) nucleic acid IVD, kit, nucleic acid technique (NAT)
2x60g cart.,12 mix&12 oral tips. Precision automix low viscosity polyvinyl siloxane impression material for crown, bridge, implant prosthetics, inlay and only impressions.
STERNGOLD DENTAL LLC
220101
In Commercial Distribution

  • 00841549115912 ()


  • Silicone dental impression material
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 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 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)
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 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
"MGB Alert® HHV-6 Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences from HHV-6. The mix consists of one probe at 0.5 nmol per vial in a 1X TE buffer solution. The probe is labeled with 6-carboxyfluorescein and has an excitation wavelength maxima of 492 nm and an emission wavelength maxima of 516 nm."
Elitechgroup Mdx LLC
800425
In Commercial Distribution

  • 03661540951565 ()
800425

  • Human herpesvirus 6 (HHV6) nucleic acid IVD, kit, nucleic acid technique (NAT)
"MGB Alert® HHV-6 Probe Mix is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect nucleic acid sequences from HHV-6. The mix consists of one probe at 0.5 nmol per vial in a 1X TE buffer solution. The probe is labeled with 6-carboxyfluorescein and has an excitation wavelength maxima of 492 nm and an emission wavelength maxima of 516 nm."
Elitechgroup Mdx LLC
800339
In Commercial Distribution

  • 03661540951343 ()
800339

  • Human herpesvirus 6 (HHV6) 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-am
In Commercial Distribution

  • 03661540950230 ()
M800583-am

  • Trichomonas vaginalis nucleic acid IVD, kit, nucleic acid technique (NAT)
MGB Alert® Trichomonas vaginalis Probe is an analyte specific reagent that contains a chemically synthesized DNA oligonucleotide designed to detect a repeated DNA fragment in Trichomonas vaginalis. The mix consists of one probe at 0.56 nmol per vial in a 1X TE buffer solution. The probe is labeled with 6-carboxyfluorescein and has an excitation wavelength maxima of 492 nm and an emission wavelength maxima of 516 nm.
Elitechgroup Mdx LLC
M800582-am
In Commercial Distribution

  • 03661540950216 ()
M800582-am

  • Trichomonas vaginalis nucleic acid IVD, kit, nucleic acid technique (NAT)
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