HBsAg Confirmatory Kit 100 Test

HBsAg Confirmatory Kit 100 Test
IMMULITE® 2000 Systems HBsAg Confirmatory Kit - 10706825

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative neutralization of Hepatitis B virus surface antigens in a clinical specimen, using Hepatitis B virus antibodies of known specificity and 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 Antigen, B Surface Antigen, Be Antigen)

Device Class: 2

Physical State: N/A

Definition: In vitro diagnostic device intended for aid in the diagnosis of chronic or acute HBV infection. HBV surface antigen (HbsAg) is also used for screening of HBV infection in pregnant women to identify neonates who are at risk of acquiring hepatitis B during perinatal period.

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: 866.3172

Third Party Flag: N

Medical Specialty: MI

Device Id: 00630414947433

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