Not required for BLA products.

Not required for BLA products.
Procleix - Procleix System Fluid Preservative

A collection of reagents and other associated materials 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, 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: MZA

Device Name: Test, Equipment, Automated Bloodborne Pathogen

Device Class: N

Physical State: N/A

Definition: N/A

Submission Type ID: 3

Review Panel: IM

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: 4

Implant Flag: N

Target Area: N/A

Regulation Number: N/A

Third Party Flag: N

Medical Specialty: N/A

Device Id: 15420045500709

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