DEVICE: Anti-HBs CalCheck (07613336159804)
Device Identifier (DI) Information
Anti-HBs CalCheck
04985354160
Not in Commercial Distribution
04985354160
Roche Diagnostics GmbH
04985354160
Not in Commercial Distribution
04985354160
Roche Diagnostics GmbH
Anti-HBs CC 3 Elecsys
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
41998 | Hepatitis B virus surface total antibody IVD, control |
A material which is used to verify the performance of 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.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LOM | Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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P010054 | 038 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
a2d90031-0496-410e-b96a-137bc7b5d687
February 13, 2024
4
August 30, 2018
February 13, 2024
4
August 30, 2018
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined