DEVICE: Elecsys HBsAg II (07613336106396)
Device Identifier (DI) Information
Elecsys HBsAg II
07914482160
Not in Commercial Distribution
07914482160
Roche Diagnostics GmbH
07914482160
Not in Commercial Distribution
07914482160
Roche Diagnostics GmbH
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
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? |
---|---|---|---|---|
48321 | Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay |
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of Hepatitis B virus surface antigen in a clinical specimen, using a chemiluminescent immunoassay method.
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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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P160019 | 000 |
P160019 | 001 |
P160019 | 003 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 2 and 8 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
b4315110-bcb2-4888-83c8-89d8b20cebcd
January 01, 2024
5
February 03, 2017
January 01, 2024
5
February 03, 2017
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