ACCUPROBE®

ACCUPROBE® - ACCUPROBE, N. GONORRHOEAE

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from Neisseria gonorrhoeae bacteria, the causative agent of gonorrhoea, in a clinical specimen using a nucleic acid technique (NAT).

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: LSL

Device Name: Dna-Reagents, Neisseria

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

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: 866.3390

Third Party Flag: N

Medical Specialty: MI

Device Id: 15420045506107

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