No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00884999002180 | 02J27-095 | 02J27-095 | UroVysion Bladder Cancer Kit | NSD | Test, fluorescence in situ hybridization (fish), for bladder cancer detection an Test, fluorescence in situ hybridization (fish), for bladder cancer detection and monitoring for recurrence | 3 | UroVysion |
2 | 00884999002142 | 02J27-025 | 02J27-025 | UroVysion Bladder Cancer Kit | NSD | Test, fluorescence in situ hybridization (fish), for bladder cancer detection an Test, fluorescence in situ hybridization (fish), for bladder cancer detection and monitoring for recurrence | 3 | UroVysion |
3 | 00884999002128 | 02J27-011 | 02J27-011 | ProbeChek UroVysion Bladder Cancer Kit Control Slides | OYU | Dna-probe kit, human chromosome | 2 | UroVysion |
4 | 00884999031357 | 8L49-030 | 8L49-30 | DNA Amp Check | PPM | General purpose reagent | 1 | Abbott |
5 | 00884999039278 | 4J94-23 | 4J94-23 | ViroSeq HIV-1 Genotyping Software v3.0 & Algorithm Advisor | NHS | Assay, genotype, hiv drug resistance, in vitro | 2 | ViroSeq |
6 | 00884999007475 | 4J94-93 | 4J94-93 | ViroSeq HIV-1 Genotyping System v2.0 | NHS | Assay, genotype, hiv drug resistance, in vitro | 2 | ViroSeq |
7 | 00884999007468 | 4J94-92 | 4J94-92 | Sequencing Consumables Kit | PPM | General purpose reagent | 1 | ViroSeq |
8 | 00884999007420 | 4J94-73 | 4J94-73 | PCR Cleanup Kit | PPM | General purpose reagent | 1 | ViroSeq |
9 | 00884999049130 | 09N77-055 | 09N77-055 | Abbott Universal Collection Kit | QJR | Reagents, 2019-novel coronavirus nucleic acid | RealTime | |
10 | 00884999049109 | 09N77-095 | 09N77-095 | Abbott RealTime SARS-CoV-2 Amplification Reagent Kit | QJR | Reagents, 2019-novel coronavirus nucleic acid | RealTime | |
11 | 00884999049086 | 09N77-085 | 09N77-085 | Abbott RealTime SARS-CoV-2 Control Kit | QJR | Reagents, 2019-novel coronavirus nucleic acid | RealTime | |
12 | 00884999049055 | 09N77-010 | 09N77-010 | Abbott RealTime SARS-CoV-2 Application CD-ROM | QJR | Reagents, 2019-novel coronavirus nucleic acid | RealTime | |
13 | 00884999048478 | 02J11-057 | 02J11-057 | VP 2000 System Software v2.1 with Protocols USB | KEY | STAINER, TISSUE, AUTOMATED | 1 | VP2000 |
14 | 00884999048065 | 06L83-008 | 06L83-008 | Abbott RealTime HIV-1 m2000 System Combined Application CD-ROM | MZF | Test, HIV detection | 2 | RealTime |
15 | 00884999047792 | 08N90-006 | 08N90-006 | Abbott RealTime IDH1m2000rt Application CD-ROM | OWD | Somatic gene mutation detection system | 3 | RealTime |
16 | 00884999047358 | 08N90-090 | 08N90-090 | Abbott RealTime IDH1 Amplification Reagent Kit | OWD | Somatic gene mutation detection system | 3 | RealTime |
17 | 00884999047341 | 08N90-080 | 08N90-080 | Abbott RealTime IDH1 Control Kit | OWD | Somatic gene mutation detection system | 3 | RealTime |
18 | 00884999047310 | 02J11-065 | 02J11-065 | VIP 2000 Upgrade Kit | KEY | STAINER, TISSUE, AUTOMATED | 1 | VP2000 |
19 | 00884999047297 | 09N21-002 | 09N21-002 | Abbott RealTime CMV m2000 System Combined Application CD-ROM | PAB | Cytomegalovirus (cmv) dna quantitative assay | 3 | RealTime |
20 | 00884999047051 | 08N82-080 | Abbott RealTime IDH2 Control Kit | OWD | Somatic gene mutation detection system | 3 | RealTime | |
21 | 00884999047044 | 08N82-090 | 08N82-090 | Abbott RealTime IDH2 Amplification Reagent Kit | OWD | Somatic gene mutation detection system | 3 | RealTime |
22 | 00884999047037 | 08N82-001 | 08N82-001 | Abbott RealTime IDH2 m2000rt Application CD-ROM | OWD | Somatic gene mutation detection system | 3 | RealTime |
23 | 00884999046603 | 03L78-061 | 03L78-061 | Abbott Proteinase K Recombinant, PCR Grade | PAB | Cytomegalovirus (cmv) dna quantitative assay | 3 | RealTime |
24 | 00884999046528 | 9K12-04 | 9K12-04 | multi-Collect Specimen Collection Kit | LSL,LIO,MKZ | DNA-REAGENTS, NEISSERIA,DEVICE, SPECIMEN COLLECTION,DNA PROBE, NUCLEIC ACID AMPL DNA-REAGENTS, NEISSERIA,DEVICE, SPECIMEN COLLECTION,DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA | Multi-Collect | |
25 | 00884999046511 | 9K12-03 | 9K12-03 | multi-Collect Specimen Collection Specimen Collection Kit | MKZ,LIO,LSL | DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA,DEVICE, SPECIMEN COLLECTION,DNA DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA,DEVICE, SPECIMEN COLLECTION,DNA-REAGENTS, NEISSERIA | Multi-Collect | |
26 | 00884999046153 | 02J11-042 | 02J11-042 | VIP 2000 Upgrade 250 mL Basin Kit | KEY | STAINER, TISSUE, AUTOMATED | 1 | VP2000 |
27 | 00884999046146 | 02J11-041 | 02J11-041 | VIP 2000 Upgrade 150 mL Basin Kit | KEY | STAINER, TISSUE, AUTOMATED | 1 | VP2000 |
28 | 00884999046122 | 02J11-063 | 02J11-063 | VP 2000 Processor, 100V | KEY | STAINER, TISSUE, AUTOMATED | 1 | VP2000 |
29 | 00884999046115 | 02J11-062 | 02J11-062 | VP 2000 Processor, 117V | KEY | STAINER, TISSUE, AUTOMATED | 1 | VP2000 |
30 | 00884999046108 | 02J11-061 | 02J11-061 | VP 2000 Processor, 230V | KEY | STAINER, TISSUE, AUTOMATED | 1 | VP2000 |
31 | 00884999045798 | 09N21-090 | 09N21-090 | Abbott RealTime CMV Amplification Reagent Kit | PAB | Cytomegalovirus (cmv) dna quantitative assay | 3 | RealTime |
32 | 00884999045781 | 09N21-080 | 09N21-080 | Abbott RealTime CMV Control Kit | PAB | Cytomegalovirus (cmv) dna quantitative assay | 3 | RealTime |
33 | 00884999045774 | 09N21-070 | 09N21-070 | Abbott RealTime CMV Calibrator Kit | PAB | Cytomegalovirus (cmv) dna quantitative assay | 3 | RealTime |
34 | 00884999042704 | 06L83-007 | 06L83-007 | Abbott RealTime HIV-1 m2000 System Combined Application CD-ROM | MZF | Test, hiv detection | 2 | RealTime |
35 | 00884999042681 | 04N45-004 | 04N45-004 | Abbott RealTime HCV m2000 System Combined Application CD-ROM | MZP | ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS | 2 | RealTime |
36 | 00884999042667 | 02N43-004 | 02N43-004 | Abbott RealTime HBV m2000 System Combined Application CD-ROM | MKT | Hepatitis Viral B DNA Detection | 3 | RealTime |
37 | 00884999042513 | 08L21-002 | 08L21-002 | Abbott RealTime HCV Genotype II m2000 System Combined Application CD-ROM | OBF | Assay, genotyping, hepatitis c virus | 2 | RealTime |
38 | 00884999038462 | 2N40-91 | 2N40-91 | Abbott RealTime HBV Amplification Reagent Kit | MKT | Hepatitis Viral B DNA Detection | 3 | RealTime |
39 | 00884999038189 | 08N16-001 | 08N16-001 | VP 2000 Pretreatment Kit | OWE | Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement | 3 | VP2000 |
40 | 00884999037762 | 2N43-03 | 2N43-03 | Abbott RealTime HBV m2000 System Combined Application CD-ROM, Version 3.0 | MKT | Hepatitis Viral B DNA Detection | 3 | RealTime |
41 | 00884999037656 | 4N45-03 | 4N45-03 | Abbott RealTime HCV m2000 System Combined Application CD-ROM, Version 3.0 | MZP | ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS | 2 | RealTime |
42 | 00884999037595 | 03N27-51 | 03N27-51 | Abbott VP2000 Processor Operations Manual, Rev. D | KEY | STAINER, TISSUE, AUTOMATED | 1 | VP2000 |
43 | 00884999037472 | 06L87-02 | 06L87-02 | Uracil-N-Glycosylase (UNG) | MZP,LSL,OBF,MZF,MKZ | ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS,DNA-REAGENTS, NEISSERIA,Assay, genotyping, hepatitis c virus,Test, hiv detection,DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA | 1 | RealTime |
44 | 00884999037434 | 1N30-67 | 1N30-67 | Abbott RealTime HCV Including Uracil-N-Glycosylase (UNG) | MZP | ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS | 2 | RealTime |
45 | 00884999037427 | 6L18-67 | 6L18-67 | Abbott RealTime HIV-1 Amplification Extended Use Including Uracil-N-Glycosylase (UNG) | MZF | Test, hiv detection | 2 | RealTime |
46 | 00884999037410 | 8L07-67 | 8L07-67 | Abbott RealTime CT/NG Amplification Reagent Extended Use Including Uracil-N-Glyc Abbott RealTime CT/NG Amplification Reagent Extended Use Including Uracil-N-Glycosylase (UNG) | LIO,MKZ,LSL | DEVICE, SPECIMEN COLLECTION,DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA,DNA DEVICE, SPECIMEN COLLECTION,DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA,DNA-REAGENTS, NEISSERIA | 1 | RealTime |
47 | 00884999037304 | 6L18-50 | 6L18-50 | Abbott RealTime HIV-1 Amplification Reagent Extended Use | MZF | Test, hiv detection | 2 | RealTime |
48 | 00884999037298 | 8L07-50 | 8L07-50 | Abbott RealTime CT/NG Amplification Reagent Extended Use with Pierceable Caps | LSL,LIO,MKZ | DNA-REAGENTS, NEISSERIA,DEVICE, SPECIMEN COLLECTION,DNA PROBE, NUCLEIC ACID AMPL DNA-REAGENTS, NEISSERIA,DEVICE, SPECIMEN COLLECTION,DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA | 1 | RealTime |
49 | 00884999037168 | 6L83-06 | 6L83-06 | Abbott RealTime HIV-1 m2000 System Combined Application CD-ROM, Version 6.0 | MZF | Test, hiv detection | 2 | RealTime |
50 | 00884999037113 | 06L98-05 | 06L98-05 | Abbott m2000 System Chlamydia trachomatis and Neisseria gonorrhoeae Application Abbott m2000 System Chlamydia trachomatis and Neisseria gonorrhoeae Application CD-ROM, Version 5.0 | LSL,LIO,MKZ | DNA-REAGENTS, NEISSERIA,DEVICE, SPECIMEN COLLECTION,DNA PROBE, NUCLEIC ACID AMPL DNA-REAGENTS, NEISSERIA,DEVICE, SPECIMEN COLLECTION,DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA | 1 | RealTime |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00875197005950 | 08160104190 | 08160104190 | cobas® Influenza A/B & RSV Nucleic acid test for use on the cobas® Liat® System | ROCHE MOLECULAR SYSTEMS, INC. | |
2 | 00875197005783 | 07460082190 | 07460082190 | cobas CTNG Positive Control Kit | ROCHE MOLECULAR SYSTEMS, INC. | |
3 | 00875197005783 | 07460082190 | 07460082190 | cobas CTNG Positive Control Kit | ROCHE MOLECULAR SYSTEMS, INC. | |
4 | 00875197005783 | 07460082190 | 07460082190 | cobas CTNG Positive Control Kit | ROCHE MOLECULAR SYSTEMS, INC. | |
5 | 00875197005776 | 07460066190 | 07460066190 | cobas CTNG Qualitative nucleic acid test for use on the cobas 6800/8800 Systems | ROCHE MOLECULAR SYSTEMS, INC. | |
6 | 00875197005776 | 07460066190 | 07460066190 | cobas CTNG Qualitative nucleic acid test for use on the cobas 6800/8800 Systems | ROCHE MOLECULAR SYSTEMS, INC. | |
7 | 00875197005776 | 07460066190 | 07460066190 | cobas CTNG Qualitative nucleic acid test for use on the cobas 6800/8800 Systems | ROCHE MOLECULAR SYSTEMS, INC. | |
8 | 00875197005738 | 07958021190 | 07958021190 | cobas PCR Media Dual Swab Sample Kit | ROCHE MOLECULAR SYSTEMS, INC. | |
9 | 00875197005738 | 07958021190 | 07958021190 | cobas PCR Media Dual Swab Sample Kit | ROCHE MOLECULAR SYSTEMS, INC. | |
10 | 00875197005738 | 07958021190 | 07958021190 | cobas PCR Media Dual Swab Sample Kit | ROCHE MOLECULAR SYSTEMS, INC. | |
11 | 00875197005721 | 07958030190 | 07958030190 | cobas® PCR Media Uni Swab Sample Kit | ROCHE MOLECULAR SYSTEMS, INC. | |
12 | 00875197005721 | 07958030190 | 07958030190 | cobas® PCR Media Uni Swab Sample Kit | ROCHE MOLECULAR SYSTEMS, INC. | |
13 | 00875197005721 | 07958030190 | 07958030190 | cobas® PCR Media Uni Swab Sample Kit | ROCHE MOLECULAR SYSTEMS, INC. | |
14 | 00875197005660 | 07402759190 | 07402759190 | cobas Liat Cleaning Tool | ROCHE MOLECULAR SYSTEMS, INC. | |
15 | 00875197005653 | 07402686190 | 07402686190 | cobas® Influenza A/B &RSV Quality Control Kit for use on the cobas® Liat® System | ROCHE MOLECULAR SYSTEMS, INC. | |
16 | 00875197005363 | 2.0 | 07102577190 | cobas® 4800 CT/NG Test v2.0 | ROCHE MOLECULAR SYSTEMS, INC. | |
17 | 00875197005363 | 2.0 | 07102577190 | cobas® 4800 CT/NG Test v2.0 | ROCHE MOLECULAR SYSTEMS, INC. | |
18 | 00875197005363 | 2.0 | 07102577190 | cobas® 4800 CT/NG Test v2.0 | ROCHE MOLECULAR SYSTEMS, INC. | |
19 | 00875197005356 | 2.0 | 07102569190 | cobas® 4800 CT/NG Test v2.0 | ROCHE MOLECULAR SYSTEMS, INC. | |
20 | 00875197005356 | 2.0 | 07102569190 | cobas® 4800 CT/NG Test v2.0 | ROCHE MOLECULAR SYSTEMS, INC. | |
21 | 00875197005356 | 2.0 | 07102569190 | cobas® 4800 CT/NG Test v2.0 | ROCHE MOLECULAR SYSTEMS, INC. | |
22 | 00875197004441 | 1.0 | 06768288190 | cobas® MRSA/SA Controls and Cofactor Kit | ROCHE MOLECULAR SYSTEMS, INC. | |
23 | 00875197004427 | 1.0 | 06768172190 | cobas® MRSA/SA Test | ROCHE MOLECULAR SYSTEMS, INC. | |
24 | 00875197004410 | 1.0 | 06768113190 | cobas® MRSA/SA Test | ROCHE MOLECULAR SYSTEMS, INC. | |
25 | 00875197003314 | 1.0 | 05235944190 | cobas® 4800 CT/NG Test | ROCHE MOLECULAR SYSTEMS, INC. | |
26 | 00875197003314 | 1.0 | 05235944190 | cobas® 4800 CT/NG Test | ROCHE MOLECULAR SYSTEMS, INC. | |
27 | 00875197003314 | 1.0 | 05235944190 | cobas® 4800 CT/NG Test | ROCHE MOLECULAR SYSTEMS, INC. | |
28 | 00875197003307 | 1.0 | 05235936190 | cobas® 4800 CT/NG Test | ROCHE MOLECULAR SYSTEMS, INC. | |
29 | 00875197003307 | 1.0 | 05235936190 | cobas® 4800 CT/NG Test | ROCHE MOLECULAR SYSTEMS, INC. | |
30 | 00875197003307 | 1.0 | 05235936190 | cobas® 4800 CT/NG Test | ROCHE MOLECULAR SYSTEMS, INC. | |
31 | 00875197003215 | 1.0 | 05235847190 | cobas® 4800 System Control Diluent Kit | ROCHE MOLECULAR SYSTEMS, INC. | |
32 | 00875197003215 | 1.0 | 05235847190 | cobas® 4800 System Control Diluent Kit | ROCHE MOLECULAR SYSTEMS, INC. | |
33 | 00875197003215 | 1.0 | 05235847190 | cobas® 4800 System Control Diluent Kit | ROCHE MOLECULAR SYSTEMS, INC. | |
34 | 00875197002997 | 1.0 | 05205743190 | LightCycler® Advanced Lysis | ROCHE MOLECULAR SYSTEMS, INC. | |
35 | 00875197002973 | 1.0 | 05205727190 | LightCycler® MRSA Advanced Test | ROCHE MOLECULAR SYSTEMS, INC. | |
36 | 00875197002911 | 1.0 | 05170516190 | cobas® PCR Female Swab Sample Kit | ROCHE MOLECULAR SYSTEMS, INC. | |
37 | 00875197002911 | 1.0 | 05170516190 | cobas® PCR Female Swab Sample Kit | ROCHE MOLECULAR SYSTEMS, INC. | |
38 | 00875197002911 | 1.0 | 05170516190 | cobas® PCR Female Swab Sample Kit | ROCHE MOLECULAR SYSTEMS, INC. | |
39 | 00875197002898 | 1.0 | 05170486190 | cobas® PCR Urine Sample Kit | ROCHE MOLECULAR SYSTEMS, INC. | |
40 | 00875197002898 | 1.0 | 05170486190 | cobas® PCR Urine Sample Kit | ROCHE MOLECULAR SYSTEMS, INC. | |
41 | 00875197002898 | 1.0 | 05170486190 | cobas® PCR Urine Sample Kit | ROCHE MOLECULAR SYSTEMS, INC. | |
42 | 00857573006409 | 10-0000-07R | The Verigene® Processor SP is an instrument which integrates sample preparation, The Verigene® Processor SP is an instrument which integrates sample preparation, target amplification, and target hybridization within a single device as part of the Verigene® System, a benchtop molecular diagnostics workstation that utilizes patented gold nanoparticle technology to detect nucleic acid targets of interest for a variety of applications. (Refurbished) | Verigene® Processor SP (Refurbished) | NANOSPHERE, INC. | |
43 | 00857573006393 | 10-0000-02R | The Verigene® Reader is the central control of the Verigene® System, a benchtop The Verigene® Reader is the central control of the Verigene® System, a benchtop molecular diagnostics workstation that utilizes patented gold nanoparticle technology to detect nucleic acid targets of interest for a variety of applications. (Refurbished) | Verigene® Reader (Refurbished) | NANOSPHERE, INC. | |
44 | 00857573006010 | 10-0000-07 | The Verigene® Processor SP is an instrument which integrates sample preparation, The Verigene® Processor SP is an instrument which integrates sample preparation, target amplification, and target hybridization within a single device as part of the Verigene® System, a benchtop molecular diagnostics workstation that utilizes patented gold nanoparticle technology to detect nucleic acid targets of interest for a variety of applications. | Verigene® Processor SP | NANOSPHERE, INC. | |
45 | 00857573006003 | 10-0000-02 | The Verigene® Reader is the central control of the Verigene® System, a benchtop The Verigene® Reader is the central control of the Verigene® System, a benchtop molecular diagnostics workstation that utilizes patented gold nanoparticle technology to detect nucleic acid targets of interest for a variety of applications. | Verigene® Reader | NANOSPHERE, INC. | |
46 | 00851458005099 | NGDS-ASY-0006 | NGDS-ASY-0006 | FilmArray® NGDS Warrior Panel - IVD reagent Biothreat Detection Kit containing 30 tests. | NGDS | BIOFIRE DEFENSE, LLC |
47 | 00851034007011 | 1 | In-vitro multiplex assay used with the Biocode MDx 3000 for the detection of gas In-vitro multiplex assay used with the Biocode MDx 3000 for the detection of gastrointestinal pathogens. | Gastrointestinal Pathogen Panel (GPP) Kit | APPLIED BIOCODE, INC. | |
48 | 00851034007004 | 1 | 41-A0051 | The BioCode MDx 3000 is an automated molecular diagnostic system for use with Ap The BioCode MDx 3000 is an automated molecular diagnostic system for use with Applied BioCode’s Barcoded Magnetic Beads (BMB) assays. | BioCode MDx 3000 | APPLIED BIOCODE, INC. |
49 | 00840733102370 | 410500 | 410500 | The revogene Carba assay performed on the revogene instrument is a qualitative i The revogene Carba assay performed on the revogene instrument is a qualitative in vitro diagnostic test designed for the detection and differentiation of the blaKPC, blaNDM, blaVIM, blaOXA-48-like and blaIMP gene sequences associated with carbapenem-non-susceptible pure colonies of Enterobacteriaceae, Acinetobacter baumannii, or Pseudomonas aeruginosa, when grown on blood agar or MacConkey agar. The revogene Carba C assay is intended as an aid for infection control in the detection of carbapenem-non-susceptible bacteria that colonize patients in healthcare settings. | Revogene Carba C | MERIDIAN BIOSCIENCE, INC. |
50 | 00840733102363 | 410200 | 410200 | The Revogene GBS LB assay performed on the Revogene Instrument is a qualitative The Revogene 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 Revogene 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 Revogene 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. | Revogene GBS LB | MERIDIAN BIOSCIENCE, INC. |