B.R.A.H.M.S Basiskit LIA

GUDID 04260157633711

B.R.A.H.M.S GmbH

Chemiluminescent immunoassay signal generation kit IVD
Primary Device ID04260157633711
NIH Device Record Keydc8af346-7ff0-4239-8c6c-7022ee5a99e9
Commercial Distribution Discontinuation2017-01-01
Commercial Distribution StatusNot in Commercial Distribution
Brand NameB.R.A.H.M.S Basiskit LIA
Version Model Number371.0
Company DUNS343844205
Company NameB.R.A.H.M.S GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104260157633711 [Primary]

FDA Product Code

NTMAntigen, Inflammatory Response Marker, Sepsis

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-08-17

Devices Manufactured by B.R.A.H.M.S GmbH

04260157632127 - B.R.A.H.M.S CgA II KRYPTOR2023-10-02
04260157632288 - B.R.A.H.M.S CgA II KRYPTOR CAL2023-06-28
04260157632295 - B.R.A.H.M.S CgA II KRYPTOR QC2023-06-28
04260157632158 - B.R.A.H.M.S sFlt-1 KRYPTOR2023-05-30
04260157632196 - B.R.A.H.M.S PlGF plus KRYPTOR2023-05-30
04260157632455 - B.R.A.H.M.S PlGF plus KRYPTOR CAL2023-05-29
04260157632462 - B.R.A.H.M.S PlGF plus KRYPTOR QC2023-05-29
04260157632479 - B.R.A.H.M.S sFlt-1 KRYPTOR CAL2023-05-29

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