What is FDA product code NJR?

A nucleic acid amplification assay system (including probes, other reagents, and instrumentation) is an aid in the identification of group b streptococci from pre-partum and intra-partum women to establish colonization status.

Immunology & Microbiology › Serological ReagentsNucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test

GenePOC™ GBS LB

Name: GenePOC™ GBS LB
Brand: GenePOC™ GBS LB

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…

Registry build 21.09.26

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..

2manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

Who Else Makes It

All of them in Jiangsu.

Chinese manufacturers registered for FDA product code NJR
Manufacturer	City	Province	Registered as	Device types
Jiangsu Macro & Micro-Test MED-Tech Co., Ltd.	Nantong	Jiangsu	Manufacturer	11
Suzhou Tianlong Biotechnology Co., Ltd.	Suzhou	Jiangsu	Manufacturer	5

Record

Regulatory record for GenePOC™ GBS LB
Listed by	Genepoc, Inc., Canada
FDA product code	NJR
Device type	Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
Device class	Class 1
Regulation	21 CFR 866.3740
Record published	2017-12-29
Record revised	2021-10-01 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date
Distribution end date	2021-09-30

Catalogue Numbers

Catalogue numbers for GenePOC™ GBS LB
Catalogue number	Size	Status
130932		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
SmartCycler Dx System	Cepheid	16
Freeze-dried Group B Streptococcus Nucleic Acid Detection Kit(Fluorescence PCR)	Jiangsu Macro & Micro-Test MED-Tech Co., Ltd.	3
Panther Fusion®	Hologic, Inc.	3
Xpert GBS LB	Cepheid	2
Xpert®	Cepheid	2
Alethia™ Group B Streptococcus	Meridian Bioscience, Inc.	1
AmpliVue	Quidel Corp.	1
Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EP	Jiangsu Macro & Micro-Test MED-Tech Co., Ltd.	1
Revogene GBS LB	Meridian Bioscience, Inc.	1
NeuMoDxTM GBS Test Strip	Neumodx Molecular, Inc.	1
Solana	Diagnostic Hybrids, Inc.	1
Aries® GBS Assay	Luminex Corporation	1

Showing 12 of 19. All products under Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K170557	2017-05-25

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.