Identity
- Trade Name
- Revogene GBS LB FDA UDI
- Generic Name
- Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 410200 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Catalog Number
- 410200 FDA UDI
- Primary DI / UDI-DI
- 00840733102363 FDA UDI
- 510(k) Number
- K170557 FDA UDI
- FDA Product Code
- NJR FDA UDIOOI FDA UDI
- GMDN Term
- Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.3740 FDA UDI862.2570 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)
Revogene GBS LB by Meridian Bioscience, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT).
- Xpert® — CEPHEID · Class I
- Xpert GBS LB — CEPHEID · Class I
- Xpert GBS LB — CEPHEID · Class I
- GeneXpert® — CEPHEID · Class I
- Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EP — Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. · Class I
- Freeze-dried Group B Streptococcus Nucleic Acid Detection Kit(Fluorescence PCR) — Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. · Class I
- Freeze-dried Group B Streptococcus Nucleic Acid Detection Kit(Fluorescence PCR) — Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. · Class I
- Group B Strep Assay — Great Basin Scientific, Inc. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Meridian Bioscience, Inc.
Sources (1)
- FDA UDI cf6a1293-f9fd-45c9-8256-9bb9b344460e 37 fields · synced Jun 1, 2026