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Revogene® GBS LB

FDA UDI

Class II (US FDA UDI)

by Meridian Bioscience Canada Inc

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
00628055344117 FDA UDI
FDA Product Code
OOI FDA UDI
NJR FDA UDI
GMDN Term
Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.2570 FDA UDI
866.3740 FDA UDI
Commercial Distribution
Not 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

Revogene® GBS LB by Meridian Bioscience Canada Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Meridian Bioscience Canada Inc

Sources (1)

  • FDA UDI 5fd3d4a7-1099-4d73-994e-d7f56ff62e6c 37 fields · synced May 30, 2026