FDA.reportPublic FDA data

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

Primary DI
04260157632288
Brand
B.R.A.H.M.S CgA II KRYPTOR CAL
Company
B.R.A.H.M.S GmbH
Model
083991N
Published
2023-06-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JITCalibrator, Secondary

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JITCalibrator, SecondaryClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260157632288PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260157632288042601576322884260157632288

GMDN Terms#

Term, Definition table
TermDefinition
Chromogranin A IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of chromogranin A in a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
343844205
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260157630543B.R.A.H.M.S PCT LIA354.1002016-08-17
04260157638259B.R.A.H.M.S PCT sensitive KRYPTOR 825.0502016-08-17
04260157630406B.R.A.H.M.S PlGF plus KRYPTOR LIN085993N2025-02-26
04260157630413B.R.A.H.M.S sFlt-1 KRYPTOR LIN084593N2025-02-26
04260157632127B.R.A.H.M.S CgA II KRYPTOR839050N839050N2023-09-22
04260157632295B.R.A.H.M.S CgA II KRYPTOR QC083992N2023-06-20
04260157633216B.R.A.H.M.S KRYPTOR compact SOLUTION 1 899812016-08-17
04260157633223B.R.A.H.M.S KRYPTOR compact SOLUTION 2 899822016-08-17
04260157633230B.R.A.H.M.S KRYPTOR compact SOLUTION 3 899832016-08-17
04260157633247B.R.A.H.M.S KRYPTOR compact SOLUTION 4899842016-08-17
04260157632158B.R.A.H.M.S sFlt-1 KRYPTOR845075N2023-05-22
04260157632196B.R.A.H.M.S PlGF plus KRYPTOR859075N2023-05-22
04260157632455B.R.A.H.M.S PlGF plus KRYPTOR CAL085991N2023-05-19
04260157632462B.R.A.H.M.S PlGF plus KRYPTOR QC085992N2023-05-19
04260157632479B.R.A.H.M.S sFlt-1 KRYPTOR CAL084591N2023-05-19
04260157632486B.R.A.H.M.S sFlt-1 KRYPTOR QC084592N2023-05-19
04260157632875B.R.A.H.M.S PCT sensitive KRYPTOR CAL825912017-08-15
04260157632882B.R.A.H.M.S PCT sensitive KRYPTOR QC 825922016-08-17
04260157638976B.R.A.H.M.S KRYPTOR compact REACT899862016-08-17
04260157638983B.R.A.H.M.S KRYPTOR compact DILCUP899852016-08-17

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08058056685391Cystatin C CalibratorsSENTINEL CH. SPAJIT2025-09-16
14560189216331CL AIA-PACK Prolactin II ADJUSTER SETTOSOH CORPORATIONJIT2025-09-01
14560189216638CL AIA-PACK hs-E2 ADJUSTER SETTOSOH CORPORATIONJIT2025-09-01
14562185395454CL AIA-PACK T3 ADJUSTER SETTOSOH CORPORATIONJIT2025-09-01
14562185399674CL AIA-PACK Progesterone ADJUSTER SETTOSOH CORPORATIONJIT2025-09-01
14562185399728CL AIA-PACK LH ADJUSTER SETTOSOH CORPORATIONJIT2025-09-01
14562185400400CL AIA-PACK FSH ADJUSTER SETTOSOH CORPORATIONJIT2025-09-01
00630414611204Atellica CH UAlb CALSiemens Healthcare Diagnostics Inc.JIT2025-08-11
04015630930609Preciset Lp(a) Gen.2Roche Diagnostics GmbHJIT2025-05-27
10758750034628VITROSORTHO CLINICAL DIAGNOSTICSJIT2024-09-18
10758750035069VITROSORTHO CLINICAL DIAGNOSTICSJIT2024-09-18
10758750034918VITROSORTHO CLINICAL DIAGNOSTICSJIT2024-04-25
10758750032716VITROSORTHO CLINICAL DIAGNOSTICSJIT2024-01-20
00811403011797ISE Calibrator LowDiamond Diagnostics Inc.JIT2023-06-05
00811403011810ISE Calibrator HighDiamond Diagnostics Inc.JIT2023-06-05
00811403013036Buffer PackDiamond Diagnostics Inc.JIT2023-06-05
00811403013180Buffer PackDiamond Diagnostics Inc.JIT2023-06-05
15099590702137Access Unconjugated Estriol CalibratorsBeckman Coulter, Inc.JIT2023-01-10
07613336166345CalSet beta-Amyloid (1-42) IIRoche Diagnostics GmbHJIT2022-12-13
00630414238708DM EXL LOCI BRAHMS PCT Cal KitSiemens Healthcare Diagnostics Inc.JIT2022-11-15
00630414610870Atellica CH LDLC CALSiemens Healthcare Diagnostics Inc.JIT2022-07-08
00630414600338Atellica™ IM VitDSiemens Healthcare Diagnostics Inc.JIT2021-05-28
00630414607047DV/DM COV2G/CV2G CALSiemens Healthcare Diagnostics Inc.JIT2021-01-22
14987481100999NEFA Standard SolutionFUJIFILM WAKO PURE CHEMICAL CORPORATIONJIT2020-10-23
00630414293523Atellica IM Calibrator 30Siemens Healthcare Diagnostics Inc.JIT2020-05-31
00630414279190Atellica CH UCFP CalibratorSiemens Healthcare Diagnostics Inc.JIT2020-03-09