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

Alethia™ Group B Streptococcus

Name: Alethia™ Group B Streptococcus
Brand: Alethia™ Group B Streptococcus

The Alethia Group B Streptococcus (GBS) assay, performed on the Alethia Incubator/Reader, is a qualitative in vitro diagnostic for the detection of Streptococcus agalactiae in enriched…

Registry build 21.09.26

The Alethia Group B Streptococcus (GBS) assay, performed on the Alethia Incubator/Reader, is a qualitative in vitro diagnostic for the detection of Streptococcus agalactiae in enriched cultures obtained from vaginal/rectal swab specimens from antepartum women. Enriched cultures are obtained by 18-24 hour incubation of vaginal/rectal swab specimens in selective broth medium, either Lim Broth, TransVag Broth or Carrot Broth. The Alethia GBS assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect Streptococcus agalactiae by targeting a segment of the Streptococcus agalactiae genome. Results from the Alethia GBS assay can be used as an aid in establishing the GBS colonization status of antepartum women. This assay does not diagnose or monitor treatment for GBS infections. The Alethia GBS assay does not provide susceptibility results. Culture isolates are needed for performing susceptibility testing as recommended for penicillin-allergic women. Alethia Group B Streptococcus is intended for use in hospital, reference or state laboratory settings. The device is not intended for nonlaboratory point-of-care use.

2manufacturers in China registered for this device type

1catalogue number

2510(k) clearances naming this product code

1recall

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 Alethia™ Group B Streptococcus
Listed by	Meridian Bioscience, Inc., United States
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
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Record published	2019-01-08

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
Storage	Storage environment temperature 2 to 27 °C

Catalogue Numbers

Catalogue numbers for Alethia™ Group B Streptococcus
Catalogue number	Size	Status
480350		In distribution

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
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
Group B Streptococcus Nucleic Acid Detection Kit(Fluorescence PCR)	Jiangsu Macro & Micro-Test MED-Tech Co., Ltd.	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
K121044	2012-05-01
K112125	2011-12-05

Recalls Naming This Product

1 recall names this product by its own identifier, the UDI on its label.

Recalls naming the identifiers of Alethia™ Group B Streptococcus
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Meridian Bioscience, Inc.	UDI-DI	2025-10-07	Class II	Nonconforming Material/Component	The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the potential for leakage and reduced buffer volume.	109 in total

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.