Amplichek I Level 3 (An assayed nucleic acid control.)

Amplichek I Level 3 (An assayed nucleic acid control.)
Amplichek - 12000530

A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of human immunodeficiency virus 1 (HIV1) nucleic acid, Hepatitis C virus nucleic acid and/or Hepatitis B virus nucleic acid in a clinical specimen.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: PMN

Device Name: Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays

Device Class: 2

Physical State: solid or liquid

Definition: Assayed external quality control material to monitor the performance of microbiology nucleic acid assays for in vitro diagnostic use.

Submission Type ID: 1

Review Panel: MI

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: For use with nucleic acid amplification microbiology assays

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Not applicable - Single or multi-analyte

Regulation Number: 866.3920

Third Party Flag: Y

Medical Specialty: MI

Device Id: 03610520530085

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