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

Nucleic Acid Detection Kit Based on Enzymatic Probe Isothermal Amplification (EP

Name: Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EP
Brand: Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EP

Catalogue number 50 tests/kit, listed by Jiangsu Macro & Micro-Test MED-Tech Co., Ltd., China, under Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test. 2 manufacturers in China are registered for this product code.

Registry build 21.09.26

2manufacturers in China registered for this device type

1catalogue number

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 Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EP
Listed by	Jiangsu Macro & Micro-Test MED-Tech Co., Ltd., China
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	Manufacturer
Premarket notification	Exempt
Record published	2022-12-06

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Label carries	lot or batch number, expiry date, manufacturing date

Catalogue Numbers

Catalogue numbers for Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EP
Catalogue number	Size	Status
50 tests/kit		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
Alethia™ Group B Streptococcus	Meridian Bioscience, Inc.	1
AmpliVue	Quidel Corp.	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

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.