- Physicians Office Resource

Atellica IM HBcT2 (REF) 500T
Atellica IM HBcT2 - 11643118

Device Description

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

Environmental Conditions

Handling Environment Temperature - Degrees Celsius

8.00
2.00

Special Storage Condition, Specify

Store upright, protect from light, do not freeze

Storage Environment Temperature - Degrees Celsius

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 Identifiers

Device Id: 00630414637877

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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