DEVICE: Elecsys Anti-HBs II (07613336230367)
Device Identifier (DI) Information
Elecsys Anti-HBs II
08498610160
In Commercial Distribution
08498610160
Roche Diagnostics GmbH
08498610160
In Commercial Distribution
08498610160
Roche Diagnostics GmbH
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
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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? |
---|---|---|---|---|
48316 | Hepatitis B virus surface total antibody IVD, kit, chemiluminescent immunoassay |
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 surface in a clinical specimen, using a chemiluminescent immunoassay method.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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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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P190034 | 007 |
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
36dc2bb9-334c-4a0b-a1ac-8265c35cb959
August 28, 2024
1
August 20, 2024
August 28, 2024
1
August 20, 2024
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