Simplexa™ Bordetella Direct

Simplexa™ Bordetella Direct
Simplexa™ Bordetella Direct - MOL2750

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

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: OZZ

Device Name: Bordetella Pertussis Dna Assay System

Device Class: 2

Physical State: Bordetella pertussis DNA detection assay systems are devices that consist of reagents and instruments for the detection of Bordetella pertussis DNA extracted from human respiratory specimens.

Definition: A qualitative in vitro diagnostic assay intended to detect Bordetella pertussis DNA extracted from human respiratory specimens. Detection of Bordetella pertussis DNA aids in the diagnosis of Bordetella pertussis respiratory infection in conjunction with other clinical and laboratory testing in patients exhibiting signs and symptoms of upper respiratory tract infection.

Submission Type ID: 1

Review Panel: MI

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: A qualitative in vitro diagnostic assay intended to Bordetella pertussis DNA extracted from human respiratory specimens.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: in vitro diagnostic assay

Regulation Number: 866.3980

Third Party Flag: N

Medical Specialty: MI

Device Id: 20816101025620

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