DEVICE: B.R.A.H.M.S Basiskit LIA (04260157633711)
Device Identifier (DI) Information
B.R.A.H.M.S Basiskit LIA
371.0
Not in Commercial Distribution
B.R.A.H.M.S GmbH
371.0
Not in Commercial Distribution
B.R.A.H.M.S GmbH
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
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? |
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58793 | Chemiluminescent immunoassay signal generation kit IVD |
A collection of reagents and other associated materials intended to be used to generate a chemiluminescent signal when performing an immunoassay on a clinical specimen. The kit is typically used in conjunction with luminescent-labelled antibodies or antigens of known characterization and may also include reference material to optimise and verify performance of the luminometer instrument.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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NTM | Antigen, Inflammatory Response Marker, Sepsis |
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
dc8af346-7ff0-4239-8c6c-7022ee5a99e9
March 29, 2018
2
August 17, 2016
March 29, 2018
2
August 17, 2016
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