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

GUDID 04260157630543

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

Procalcitonin (PCT) IVD, kit, chemiluminescent immunoassay
Primary Device ID04260157630543
NIH Device Record Key4844272d-f851-4c84-a715-b28c1fa06ee8
Commercial Distribution Discontinuation2017-01-01
Commercial Distribution StatusNot in Commercial Distribution
Brand NameB.R.A.H.M.S PCT LIA
Version Model Number354.100
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
GS104260157630543 [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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.