DEVICE: B.R.A.H.M.S PCT sensitive KRYPTOR (04260157638259)
Device Identifier (DI) Information
B.R.A.H.M.S PCT sensitive KRYPTOR
825.050
In Commercial Distribution
B.R.A.H.M.S GmbH
825.050
In Commercial Distribution
B.R.A.H.M.S GmbH
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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Yes | |
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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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54313 | Procalcitonin (PCT) IVD, kit, fluorescent immunoassay |
A collection of reagents and other associated materials intended to be used for the quantitative measurement of procalcitonin (PCT) in a clinical specimen, using a fluorescent immunoassay method.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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PMT | Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens |
NTM | Antigen, Inflammatory Response Marker, Sepsis |
PRI | Procalcitonin Assay |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K171338 | 000 |
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
89009b8c-f36c-4804-8d9d-1d7bc2a8abde
May 25, 2023
4
August 17, 2016
May 25, 2023
4
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