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The Verigene® Clostridium difficile Nucleic Acid Test (CDF) is a qualitative multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA), toxin B (tcdB), and tcdC gene sequences of toxigenic Clostridium difficile and for presumptive identification of PCR ribotype 027 strains from unformed (liquid or soft) stool specimens collected from patients suspected of having C. difficile infection (CDI).
LUMINEX CORPORATION
20-009-022
20-009-022
- Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray
The xTAG® Gastrointestinal Pathogen Panel (GPP) is a qualitative multiplex test intended for the simultaneous detection and identification of nucleic acids from multiple gastroenteritis causing viruses, parasites and bacteria (including toxin gene detection) in human stool samples that are fresh, frozen or in a holding medium, from individuals with signs and symptoms of infectious colitis or gastroenteritis.
Luminex Molecular Diagnostics, Inc
I032C0316
In Commercial Distribution
- 00840487100493 ()
I032C0316
- Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
The Verigene® Clostridium difficile Nucleic Acid Test (CDF) is a qualitative multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA), toxin B (tcdB), and tcdC gene sequences of toxigenic Clostridium difficile and for presumptive identification of PCR ribotype 027 strains from unformed (liquid or soft) stool specimens collected from patients suspected of having C. difficile infection (CDI).
LUMINEX CORPORATION
20-006-022
20-006-022
- Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray
The Verigene® Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and identification of common pathogenic enteric bacteria, viruses, and genetic virulence markers from liquid or soft stool preserved in Cary-Blair medium, collected from individuals with signs and symptoms of gastrointestinal infection.
LUMINEX CORPORATION
30-002-023
30-002-023
- Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray
The Verigene® Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and identification of common pathogenic enteric bacteria, viruses, and genetic virulence markers from liquid or soft stool preserved in Cary-Blair medium, collected from individuals with signs and symptoms of gastrointestinal infection.
LUMINEX CORPORATION
20-009-023
20-009-023
- Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray
The Verigene® Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and identification of common pathogenic enteric bacteria, viruses, and genetic virulence markers from liquid or soft stool preserved in Cary-Blair medium, collected from individuals with signs and symptoms of gastrointestinal infection.
LUMINEX CORPORATION
20-011-023
20-011-023
- Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray
The Verigene® Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and identification of common pathogenic enteric bacteria, viruses, and genetic virulence markers from liquid or soft stool preserved in Cary-Blair medium, collected from individuals with signs and symptoms of gastrointestinal infection.
LUMINEX CORPORATION
20-006-023
20-006-023
- Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray
Helix Elite™ Molecular Standards Inactivated Rotavirus Strain Simian SA-11
MICROBIOLOGICS INC.
HE0027N
In Commercial Distribution
- 10845357042016 ()
HE0027N
- Multiple-type gastrointestinal pathogen nucleic acid IVD, control
Helix Elite™ Molecular Standards Cyclospora cayetanensis Synthetic DNA
MICROBIOLOGICS INC.
HE0025S
Not in Commercial Distribution
- 10845357041965 ()
HE0025S
- Multiple-type gastrointestinal pathogen nucleic acid IVD, control
Helix Elite™ Molecular Standards Dientamoeba fragilis Synthetic DNA
MICROBIOLOGICS INC.
HE0015S
Not in Commercial Distribution
- 10845357041873 ()
HE0015S
- Multiple-type gastrointestinal pathogen nucleic acid IVD, control
Helix Elite™ Molecular Standards Norovirus GI.1 Synthetic RNA
MICROBIOLOGICS INC.
HE0013S
In Commercial Distribution
- 10845357041859 ()
HE0013S
- Multiple-type gastrointestinal pathogen nucleic acid IVD, control
Helix Elite™ Molecular Standards Norovirus GII.4 Synthetic RNA
MICROBIOLOGICS INC.
HE0012S
In Commercial Distribution
- 10845357041842 ()
HE0012S
- Multiple-type gastrointestinal pathogen nucleic acid IVD, control
Helix Elite™ Molecular Standards Entamoeba dispar Synthetic DNA
MICROBIOLOGICS INC.
HE0007S
Not in Commercial Distribution
- 10845357041798 ()
HE0007S
- Multiple-type gastrointestinal pathogen nucleic acid IVD, control
Helix Elite™ Molecular Standards Entamoeba histolytica Synthetic DNA
MICROBIOLOGICS INC.
HE0006S
Not in Commercial Distribution
- 10845357041781 ()
HE0006S
- Multiple-type gastrointestinal pathogen nucleic acid IVD, control
Helix Elite™ Molecular Standards Giardia lamblia Synthetic DNA
MICROBIOLOGICS INC.
HE0005S
Not in Commercial Distribution
- 10845357041774 ()
HE0005S
- Multiple-type gastrointestinal pathogen nucleic acid IVD, control
Helix Elite™ Molecular Standards Encephalitozoon intestinalis Synthetic DNA
MICROBIOLOGICS INC.
HE0004S
Not in Commercial Distribution
- 10845357041767 ()
HE0004S
- Multiple-type gastrointestinal pathogen nucleic acid IVD, control
Helix Elite™ Molecular Standards Enterocytozoon bieneusi Synthetic DNA
MICROBIOLOGICS INC.
HE0003S
Not in Commercial Distribution
- 10845357041750 ()
HE0003S
- Multiple-type gastrointestinal pathogen nucleic acid IVD, control
Helix Elite™ Molecular Standards Cryptosporidium parvum Synthetic DNA
MICROBIOLOGICS INC.
HE0002S
Not in Commercial Distribution
- 10845357041743 ()
HE0002S
- Multiple-type gastrointestinal pathogen nucleic acid IVD, control
Helix Elite™ Molecular Standards Cryptosporidium hominis Synthetic DNA
MICROBIOLOGICS INC.
HE0001S
Not in Commercial Distribution
- 10845357041736 ()
HE0001S
- Multiple-type gastrointestinal pathogen nucleic acid IVD, control
RIM E. coli O157:H7 Latex 50TST/KT
REMEL, INC.
R24250
In Commercial Distribution
- 00848838026768 ()
R24250
- Escherichia coli antigen IVD, kit, rapid agglutination, clinical
The EasyScreen™ Gastrointestinal Parasite PCR Positive Control (PC-PROT-001) is a control material for nucleic acid testing of patient clinical samples. It is designed to provide a positive PCR signal for each of the protozoan targets in the EasyScreen™ Gastrointestinal Parasite Detection Kit (EP005). The Positive Control does not require processing and is designed to be added directly to the PCR mastermix when a positive signal in all detection channels is required for quality control purposes.
This Positive Control demonstrates that all PCR targets are being detected as expected, and does not provide any results from clinical specimens. This Positive Control is for Investigational in vitro Diagnostic (IVD) Use Only in hospital and pathology laboratories or similar, by trained personnel.
GENETIC SIGNATURES LIMITED
1
In Commercial Distribution
- 09351179004070 ()
PC-PROT-001
- Multiple-type gastrointestinal pathogen nucleic acid IVD, control
No Description
QIAGEN GmbH
V1
In Commercial Distribution
- 04053228049166 ()
691424
- Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
QIAGEN GmbH
V1
In Commercial Distribution
- 04053228048381 ()
691423
- Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
QIAGEN GmbH
V2
In Commercial Distribution
- 04053228043249 ()
691421
- Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
Kit BD MAX Enteric Viral Panel
BECTON, DICKINSON AND COMPANY
443985
In Commercial Distribution
- 00382904439859 ()
443985
- Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
Kit BD MAX Enteric Parasite Panel
BECTON, DICKINSON AND COMPANY
442960
In Commercial Distribution
- 00382904429607 ()
442960
- Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
BD MAX™ Enteric Parasite Panel (US/CAN) Contains: 24 Master Mix, 24 Extraction Tubes, 24 1.5 mL Sample Buffer tubes, 25 Septum Caps, 24 Strips Containing, Wash Buffer, Elution Buffer, Neutralization Buffer
Geneohm Sciences Canada Inc
443380
Not in Commercial Distribution
- 00382904433802 ()
443380
- Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
The Verigene® Clostridium difficile Nucleic Acid Test (CDF) is a qualitative multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA), toxin B (tcdB), and tcdC gene sequences of toxigenic Clostridium difficile and for presumptive identification of PCR ribotype 027 strains from unformed (liquid or soft) stool specimens collected from patients suspected of having C. difficile infection (CDI).
NANOSPHERE, INC.
30-002-022
Not in Commercial Distribution
- 00857573006362 ()
- Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray
The Verigene® Clostridium difficile Nucleic Acid Test (CDF) is a qualitative multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA), toxin B (tcdB), and tcdC gene sequences of toxigenic Clostridium difficile and for presumptive identification of PCR ribotype 027 strains from unformed (liquid or soft) stool specimens collected from patients suspected of having C. difficile infection (CDI).
NANOSPHERE, INC.
20-011-022
Not in Commercial Distribution
- 00857573006317 ()
- Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray
The Verigene® Clostridium difficile Nucleic Acid Test (CDF) is a qualitative multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA), toxin B (tcdB), and tcdC gene sequences of toxigenic Clostridium difficile and for presumptive identification of PCR ribotype 027 strains from unformed (liquid or soft) stool specimens collected from patients suspected of having C. difficile infection (CDI).
NANOSPHERE, INC.
20-009-022
Not in Commercial Distribution
- 00857573006256 ()
- Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray
The Verigene® Clostridium difficile Nucleic Acid Test (CDF) is a qualitative multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA), toxin B (tcdB), and tcdC gene sequences of toxigenic Clostridium difficile and for presumptive identification of PCR ribotype 027 strains from unformed (liquid or soft) stool specimens collected from patients suspected of having C. difficile infection (CDI).
NANOSPHERE, INC.
20-006-022
Not in Commercial Distribution
- 00857573006157 ()
- Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray
The Verigene® Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and identification of common pathogenic enteric bacteria, viruses, and genetic virulence markers from liquid or soft stool preserved in Cary-Blair medium, collected from individuals with signs and symptoms of gastrointestinal infection.
NANOSPHERE, INC.
20-011-023
Not in Commercial Distribution
- 00857573006089 ()
- Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray
The Verigene® Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and identification of common pathogenic enteric bacteria, viruses, and genetic virulence markers from liquid or soft stool preserved in Cary-Blair medium, collected from individuals with signs and symptoms of gastrointestinal infection.
NANOSPHERE, INC.
30-002-023
Not in Commercial Distribution
- 00857573006065 ()
- Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray
The Verigene® Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and identification of common pathogenic enteric bacteria, viruses, and genetic virulence markers from liquid or soft stool preserved in Cary-Blair medium, collected from individuals with signs and symptoms of gastrointestinal infection.
NANOSPHERE, INC.
20-009-023
Not in Commercial Distribution
- 00857573006058 ()
- Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray
The Verigene® Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and identification of common pathogenic enteric bacteria, viruses, and genetic virulence markers from liquid or soft stool preserved in Cary-Blair medium, collected from individuals with signs and symptoms of gastrointestinal infection.
NANOSPHERE, INC.
20-006-023
Not in Commercial Distribution
- 00857573006041 ()
- Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray
Kit containing calibrators and controls for MDx 3000.
APPLIED BIOCODE, INC.
1
In Commercial Distribution
- 00851034007028 ()
64-C0002
- Multiple-type gastrointestinal pathogen nucleic acid IVD, calibrator
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)
Disposable Needle Guides for use with Mindray 65EC10EA, 6CV1(s,P), CB10-4(s,P,E), V10-4(s), V10-4B(s,p), V11-3(E), V11-3B(E), V11-3W(s,E), V11-3H(E,U); Wisonic EV10-4; Landwind EC4-9; Samsung EC4-9IS, EC4-9ES, ER4-9ES; GE IC5-9; VINNO G4-9E, X4-9E; Zoncare 6E1CD Ultrasound Transducers
JingFang Precision Medical Device(Shenzhen) Co., Ltd.
DE-001
In Commercial Distribution
- 16971554725019 ()
- 06971554725012 ()
DE-001
- Needle guide, single-use
Navigator, Navi-Port Pendant
Medical Illumination International Inc.
NAV-NP-
In Commercial Distribution
- 01816835023942 ()
- 00816835023943 ()
- General utility supply system, ceiling-mounted
Navigator, Dual Arm Retractable Pendant
Medical Illumination International Inc.
NAV-DAR-
In Commercial Distribution
- 01816835023935 ()
- 00816835023936 ()
- General utility supply system, ceiling-mounted
Navigator, Single Arm Retractable Pendant
Medical Illumination International Inc.
NAV-SAR-
In Commercial Distribution
- 01816835023928 ()
- 00816835023929 ()
- General utility supply system, ceiling-mounted
Navigator, Dual Arm Fixed Pendant
Medical Illumination International Inc.
NAV-DAF-
In Commercial Distribution
- 01816835023911 ()
- 00816835023912 ()
- General utility supply system, ceiling-mounted
Navigator, Single Arm Fixed Pendant
Medical Illumination International Inc.
NAV-SAF-
In Commercial Distribution
- 01816835023904 ()
- 00816835023905 ()
- General utility supply system, ceiling-mounted
Medical Ceiling Supply Units
Maquet (Suzhou) Co. LTD
MODUEVO BRIDGE
In Commercial Distribution
- 06970283131026 ()
- General utility supply system, ceiling-mounted
Medical Ceiling Supply Units
Maquet (Suzhou) Co. LTD
CARGOLIFT
In Commercial Distribution
- 06970283131019 ()
- General utility supply system, ceiling-mounted
Medical Ceiling Supply Units
Maquet (Suzhou) Co. LTD
ENERGY
In Commercial Distribution
- 06970283131002 ()
- General utility supply system, ceiling-mounted
Medical Ceiling Supply Units
Maquet (Suzhou) Co. LTD
PLG-II
In Commercial Distribution
- 06970283130999 ()
- General utility supply system, ceiling-mounted
Medical Ceiling Supply Units
Maquet (Suzhou) Co. LTD
MODUEVO-MA
In Commercial Distribution
- 06970283130982 ()
- General utility supply system, ceiling-mounted
Equipment Management System
STRYKER COMMUNICATIONS INC.
0682400550
In Commercial Distribution
- 07613327400502 ()
0682400550
- General utility supply system, ceiling-mounted
No Description
Ondal Medical Systems GmbH
M6
In Commercial Distribution
- 04061591000202 ()
- General utility supply system, ceiling-mounted