HBc IgM (aHBcM) QC Kit
Atellica™ IM aHBcM QC - 10995450
Device Description
A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of immunoglobulin M (IgM) antibodies to the Hepatitis B virus core antigen in a clinical specimen.
Environmental Conditions
- Store Upright, Protect from Light, Do not freeze, Resuspend.
- 8.00
- 2.00
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: SEI
Device Name: Qualitative And Quantitative Hepatitis B Virus Antibody Assays
Device Class: 2
Physical State: Patient specimen, assay reagents, instruments
Definition: In vitro diagnostic devices intended for use in the detection of antibodies to HBV. These devices are intended to aid in the diagnosis of HBV infection in persons with signs and symptoms of hepatitis and in persons at risk for HBV infection. Anti-HBs assay results may be used as an aid in the determination of susceptibility to HBV infection in individuals prior to or following HBV vaccination or when vaccination status is unknown.
Submission Type ID: 1
Review Panel: MI
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: Assays measure antibodies in biological samples by enzymatic reactions. Assay techniques determine sample concentrations based on the intensity of the signal emitted by a chemical and biological reaction.
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: Blood, serum, plasma
Regulation Number: 866.3173
Third Party Flag: N
Medical Specialty: MI
Device IdentifiersDevice Id: 00630414597805
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
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