Other products from "GENEPOC INC"
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 00628055344018 130932 130932 The GenePOC™ GBS LB assay performed on the revogene™ instrument is a qualitative The GenePOC™ GBS LB assay performed on the revogene™ instrument is a qualitative in vitro diagnostic test designed to detect Group B Streptococcus (GBS) DNA from 18-24 hour LIM broth enrichments of vaginal/rectal specimen swabs obtained from pregnant women. The GenePOC GBS LB assay utilizes automated sample processing and real-time polymerase chain reaction (PCR) to detect a cfb gene sequence specific to the Streptococcus agalactiae genome.The GenePOC GBS LB assay is indicated for the identification of antepartum GBS colonization and does not provide susceptibility results. It is not intended to diagnose or monitor treatment of GBS infection. Culture isolates are needed for performing susceptibility testing as recommended for penicillin-allergic women.. NJR Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test 1 GenePOC™ GBS LB
2 00628055344025 132994 132994 The GenePOC™ CDiff assay performed on the revogene™ instrument is a qualitative The GenePOC™ CDiff assay performed on the revogene™ instrument is a qualitative in vitro diagnostic test that utilizes automated sample processing and real-time polymerase chain reaction (PCR) to detect the toxin B (tcdB) gene of toxigenic Clostridium difficile (C. difficile) in unformed (liquid or soft) stool specimens obtained from patients suspected of having C. difficile infection (CDI). The GenePOC CDiff assay is intended to aid in the diagnosis of CDI. OZN C.Difficile Toxin Gene Amplification Assay 2 GenePOC™ CDiff
3 00628055344001 130840 130840 The revogene™ instrument is intended for in vitro diagnostic (IVD) use in perfor The revogene™ instrument is intended for in vitro diagnostic (IVD) use in performing nucleic acid testing of specific IVD assays in clinical laboratories. The revogene is capable of automated lysis and dilution of samples originating from various clinical specimen types. revogene performs automated amplification and detection of target nucleic acid sequences by fluorescence-based real-time PCR. OOI Real Time Nucleic Acid Amplification System 2 revogene™
4 00628055344032 132331 132331 The MOCK PIE is a re-usable PIE intended for use in conjunction with the revogen The MOCK PIE is a re-usable PIE intended for use in conjunction with the revogene™ instrument and GenePOC assays. The MOCK PIE simulates the presence of an assay PIE for thermal and rotational balance when the number of assay PIEs is lower then eight in a run. OOI Real Time Nucleic Acid Amplification System 2 MOCK PIE
5 00628055344087 133674 133674 The GenePOC Strep A assay, performed on the revogene instrument, is an automated The GenePOC Strep A assay, performed on the revogene instrument, is an automated, qualitative in vitro diagnostic test that utilizes real-time polymerase chain reaction (PCR) for the direct detection of Streptococcus pyogenes (Group A B-hemolytic Streptococcus) nucleic acids from throat swab specimens obtained from patients with signs and symptoms of pharyngitis. The GenePOC Strep A assay is intended for use as an aid in the diagnosis of Group A Streptococcus infection. OOI,PGX Real Time Nucleic Acid Amplification System,Groups A, C And G Beta-Hemolytic Str Real Time Nucleic Acid Amplification System,Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System 2 GenePOC™ Strep A
Other products with the same Product Codes "OOI, PMY"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 07332940006822 INFINITY48-16 900-0453 Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, GeneXpert Infinity-80 GeneXpert® CEPHEID
2 07332940007720 GX-INFINITY 80 GX-INFINITY 80 Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, GeneXpert Infinity-80 GeneXpert® CEPHEID
3 07332940007713 GX-INFINITY 48S GX-INFINITY 48S Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, GeneXpert Infinity-80 GeneXpert® CEPHEID
4 07332940007706 GX-XVI R2 GX-XVI R2 XPERT, GENEXPERT DX SYSTEM GeneXpert® CEPHEID
5 07332940007690 GX-IV R2 GX-IV R2 XPERT, GENEXPERT DX SYSTEM GeneXpert® CEPHEID
6 07332940007683 GX-II R2 GX-II R2 XPERT, GENEXPERT DX SYSTEM GeneXpert® CEPHEID
7 07332940007195 GXIV-HUB 900-0828 Xpress System GeneXpert® CEPHEID
8 07332940006860 INFINITY 48-48 900-0457 XPERT, GENEXPERT DX SYSTEM GeneXpert Infinity-80 System CEPHEID
9 07332940006853 INFINITY 48-40 900-0456 Additional catalog number: 900-0456R GeneXpert Infinity-80 System CEPHEID
10 07332940006846 INFINITY 48-32 900-0455 Additional catalog number: 900-0455R GeneXpert Infinity-80 System CEPHEID
11 07332940006839 INFINITY 48-24 900-0454 Additional catalog number: 900-0454R GeneXpert Infinity-80 System CEPHEID
12 07332940006815 GXIV-1 900-0425 XPERT, GENEXPERT DX SYSTEM GeneXpert Dx System CEPHEID
13 07332940006761 GXXVI-4 900-0398 XPERT, GENEXPERT DX SYSTEM GeneXpert Dx System CEPHEID
14 07332940006754 GXXVI-8 900-0397 XPERT, GENEXPERT DX SYSTEM GeneXpert Dx System CEPHEID
15 07332940006747 GXXVI-16 900-0395 XPERT, GENEXPERT DX SYSTEM GeneXpert Dx System CEPHEID
16 07332940006730 GXXVI-12 900-0391 XPERT, GENEXPERT DX SYSTEM GeneXpert Dx System CEPHEID
17 07332940006723 GXIV-3 900-0144 XPERT, GENEXPERT DX SYSTEM GeneXpert Dx System CEPHEID
18 07332940006716 GXIV-1 900-0141 XPERT, GENEXPERT DX SYSTEM GeneXpert Dx System CEPHEID
19 07332940006709 GXIV-3 900-0139 XPERT, GENEXPERT DX SYSTEM GeneXpert Dx System CEPHEID
20 07332940004408 GXXVI-4-R 900-0518R Certified Pre-Owned GeneXpert Dx System CEPHEID
21 07332940004392 GXXVI-8-R 900-0519R Certified Pre-Owned GeneXpert Dx System CEPHEID
22 07332940004385 GXXVI-12-R 900-0520R Certified Pre-Owned GeneXpert Dx System CEPHEID
23 07332940004378 GXXVI-16-R 900-0521R Certified Pre-Owned GeneXpert Dx System CEPHEID
24 07332940004361 GX-I 900-0523 XPERT, GENEXPERT DX SYSTEM GeneXpert Dx System CEPHEID
25 07332940004354 INFINITY48-16 900-0536 GeneXpert Infinity-48s System CEPHEID
26 07332940004347 INFINITY48-24 900-0537 GeneXpert Infinity-48s System CEPHEID
27 07332940004330 INFINITY 48-32 900-0538 GeneXpert Infinity-48s System CEPHEID
28 07332940004323 INFINITY 48-40 900-0539 GeneXpert Infinity-48s System CEPHEID
29 07332940004316 INFINITY 48-48 900-0540 Additional catalog numbers: 900-0540L, 900-0540R GeneXpert Infinity-48s System CEPHEID
30 07332940004309 GXII-2 900-0542 XPERT, GENEXPERT DX SYSTEM GeneXpert Dx System CEPHEID
31 07332940004194 GX-I 900-0423 XPERT, GENEXPERT DX SYSTEM GeneXpert Dx System CEPHEID
32 07332940004170 GXIV-2 900-0424 Additional catalog number: 900-0424R GeneXpert Dx System CEPHEID
33 07332940004163 GXXVI-16 900-0426 XPERT, GENEXPERT DX SYSTEM GeneXpert Dx System CEPHEID
34 07332940004156 GXXVI-12 900-0427 XPERT, GENEXPERT DX SYSTEM GeneXpert Dx System CEPHEID
35 07332940004149 GXXVI-8, GXXVI-12 900-0428 XPERT, GENEXPERT DX SYSTEM GeneXpert Dx System CEPHEID
36 07332940004132 GXXVI-4, GXXVI-4-8 900-0429 XPERT, GENEXPERT DX SYSTEM GeneXpert Dx System CEPHEID
37 07332940004125 GXIV-3 900-0433 XPERT, GENEXPERT DX SYSTEM GeneXpert Dx System CEPHEID
38 07332940004071 GXXVI-16 900-0381 XPERT, GENEXPERT DX SYSTEM GeneXpert Dx System CEPHEID
39 07332940004057 GXXVI-8 900-0392 XPERT, GENEXPERT DX SYSTEM GeneXpert Dx System CEPHEID
40 07332940004040 GXXVI-4 900-0393 XPERT, GENEXPERT DX SYSTEM GeneXpert Dx System CEPHEID
41 07332940004033 GXIV-4 900-0400 XPERT, GENEXPERT DX SYSTEM GeneXpert Dx System CEPHEID
42 07332940004019 INFINITY 80-40 900-0498 GeneXpert Infinity-80 System CEPHEID
43 07332940004002 INFINITY 80-48 900-0499 GeneXpert Infinity-80 System CEPHEID
44 07332940003999 INFINITY 80-56 900-0500 GeneXpert Infinity-80 System CEPHEID
45 07332940003982 INFINITY 80-64 900-0501 GeneXpert Infinity-80 System CEPHEID
46 07332940003975 INFINITY 80-72 900-0502 GeneXpert Infinity-80 System CEPHEID
47 07332940003968 INFINITY 80-80 900-0503 GeneXpert Infinity-80 System CEPHEID
48 07332940003951 GXII-1-R 900-0505R Certified Pre-Owned GeneXpert Dx System CEPHEID
49 07332940003937 GXIV-1-R 900-0510R Certified Pre-Owned GeneXpert Dx System CEPHEID
50 07332940003920 GXIV-2-R 900-0511R Certified Pre-Owned GeneXpert Dx System CEPHEID