B.R.A.H.M.S KRYPTOR compact DILCUP

GUDID 04260157638983

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

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Primary Device ID04260157638983
NIH Device Record Key66c823e7-30e0-46b3-b7f3-ca21d513cbf7
Commercial Distribution StatusIn Commercial Distribution
Brand NameB.R.A.H.M.S KRYPTOR compact DILCUP
Version Model Number89985
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104260157638983 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JZTFluorometer
PMTDevice To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
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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