B.R.A.H.M.S CgA II KRYPTOR CAL

GUDID 04260157632288

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

Chromogranin A IVD, calibrator Chromogranin A IVD, calibrator Chromogranin A IVD, calibrator Chromogranin A IVD, calibrator Chromogranin A IVD, calibrator Chromogranin A IVD, calibrator Chromogranin A IVD, calibrator Chromogranin A IVD, calibrator Chromogranin A IVD, calibrator Chromogranin A IVD, calibrator Chromogranin A IVD, calibrator Chromogranin A IVD, calibrator Chromogranin A IVD, calibrator Chromogranin A IVD, calibrator Chromogranin A IVD, calibrator Chromogranin A IVD, calibrator Chromogranin A IVD, calibrator
Primary Device ID04260157632288
NIH Device Record Key5000ed2c-9007-4ebc-8432-be4713cc2a56
Commercial Distribution StatusIn Commercial Distribution
Brand NameB.R.A.H.M.S CgA II KRYPTOR CAL
Version Model Number083991N
Company DUNS343844205
Company NameB.R.A.H.M.S GmbH
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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
GS104260157632288 [Primary]

FDA Product Code

JITCalibrator, Secondary

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-28
Device Publish Date2023-06-20

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
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.