DEVICE: COBAS® TaqMan® HBV Test, For Use With The High Pure System (00875197002003)
Device Identifier (DI) Information
COBAS® TaqMan® HBV Test, For Use With The High Pure System
03577163190
In Commercial Distribution
03577163190
Roche Molecular Systems, Inc.
03577163190
In Commercial Distribution
03577163190
Roche Molecular Systems, Inc.
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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48307 | Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT) |
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of Hepatitis B virus nucleic acid in a clinical specimen, using a nucleic acid technique (NAT). The nucleic acids detected may include genes encoding the core protein, surface antigen, e-antigen, and/or other genome regions.
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FDA Product Code
[?]Product Code | Product Code Name |
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MKT | Hepatitis Viral B DNA Detection |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
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
563eb0da-6193-4478-9686-8505f212d8d5
April 21, 2021
3
September 10, 2014
April 21, 2021
3
September 10, 2014
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