AmpliVue GBS Assay


Product Overview

AmpliVue GBS Assay
AmpliVue - GBS Assay


Device Description

A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple types of microorganisms associated with neonatal disease, in a clinical specimen, using a nucleic acid technique (NAT). Microorganisms detected may include, but are not limited to, Group B Streptococcus/Streptococcus agalactiae (GBS), Listeria monocytogenes, Escherichia coli (E. coli), cytomegalovirus, Staphylococcus aureus, Chlamydia trachomatis and Ureaplasma urealyticum/parvum.


Environmental Conditions

No Data Available


Device Sizes

No Data Available


Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available


Product Codes

Code: NJR

Device Name: Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test

Device Class: 1

Physical State: N/A

Definition: 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.

Submission Type ID: 4

Review Panel: MI

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 866.3740

Third Party Flag: N

Medical Specialty: MI


Device Identifiers

Device Id: 30014613312024

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A


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