VIROTROL I (An unassayed (human) serological control.)

VIROTROL I (An unassayed (human) serological control.)
VIROTROL - 00101E

A material which is used to verify the performance of a number of assays intended to be used for the qualitative and/or quantitative detection of antigens and/or antibodies from one or multiple blood-borne viruses, in a clinical specimen. Viruses intended to be detected may include (but are not limited to) human immunodeficiency virus 1 and 2 (HIV1 and HIV2), Hepatitis B virus, Hepatitis C virus and human T-cell lymphotrophic virus 1 and/or 2 (HTLV1 and/or HTLV2).

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: KSF

Device Name: Kit, Quality Control For Blood Banking Reagents

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: HE

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: 864.9650

Third Party Flag: N

Medical Specialty: HE

Device Id: 00847661005537

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