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 IdentifiersDevice 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