Anti
MONOLISA™ - 26154
Device Description
A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of total antibodies to the Hepatitis B virus surface in a clinical specimen.
Environmental Conditions
- 8.00
- 2.00
Device Sizes
- Total Volume: 1.8 Milliliter
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
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 IdentifiersDevice Id: 00847865002097
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