VITROS Immunodiagnostic Products HBsAg Calibrator

VITROS Immunodiagnostic Products HBsAg Calibrator
VITROS - 6801323

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of Hepatitis B virus surface antigen in a clinical specimen, using a chemiluminescent immunoassay method.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: LOM

Device Name: Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

Device Class: 3

Physical State: N/A

Definition: N/A

Submission Type ID: 2

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: N/A

Third Party Flag: N

Medical Specialty: N/A

Device Id: 10758750001071

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

Device Id: 20758750001078

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 10758750001071

Package Quantity: 30

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Case