GROUP A STREPTOCOCCUS

GROUP A STREPTOCOCCUS - GROUP A STREP DIRECT TEST (GASD) 100T

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple bacteria associated with upper and/or lower respiratory disease, which may include multiple genes conferring resistance to antimicrobial drugs, in a clinical specimen using a nucleic acid technique (NAT). Bacteria detected may include (but are not limited to) Streptococcus pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae, Chlamydophila psittaci, Chlamydia pneumonia, Coxiella burnetii, Legionella pneumophila and/or Bordetella pertussis.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: MDK

Device Name: Dna-Probe, Reagents, Streptococcal

Device Class: 1

Physical State: N/A

Definition: N/A

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 Id: 15420045506305

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