FDA.reportPublic FDA data

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

Primary DI
04260157632295
Brand
B.R.A.H.M.S CgA II KRYPTOR QC
Company
B.R.A.H.M.S GmbH
Model
083992N
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
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)Clinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260157632295PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260157632295042601576322954260157632295

GMDN Terms#

Term, Definition table
TermDefinition
Chromogranin A IVD, controlA material which is used to verify the performance of 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
04260157632288B.R.A.H.M.S CgA II KRYPTOR CAL083991N2023-06-20
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850011135891VALIDATELgc Clinical Diagnostics, Inc.JJX2026-06-02
00630414608273ADVIA Centaur Tumor Marker Quality Control (TM QC)Siemens Healthcare Diagnostics Inc.JJX2026-05-29
00630414622859Atellica IM Tumor Marker Quality Control (TM QC)Siemens Healthcare Diagnostics Inc.JJX2026-05-29
07613336234457PreciControl SyphilisRoche Diagnostics GmbHJJX2026-05-15
30732671309403PipAMITY HOLDINGS, LLCJJX2026-04-16
10612479280509McKessonMCKESSON MEDICAL-SURGICAL INC.JJX2025-12-01
10840330706541TRUE METRIXTRIVIDIA HEALTH, INC.JJX2025-11-25
00021292015398TRUE METRIXTRIVIDIA HEALTH, INC.JJX2025-10-02
00021292015404TRUE METRIXTRIVIDIA HEALTH, INC.JJX2025-10-02
00021292015411TRUE METRIXTRIVIDIA HEALTH, INC.JJX2025-10-02
08058056685407Cystatin C ControlsSENTINEL CH. SPAJJX2025-09-16
10758750035380VITROSORTHO CLINICAL DIAGNOSTICSJJX2025-05-20
10758750035076VITROSORTHO CLINICAL DIAGNOSTICSJJX2024-09-18
00021292015091TRUENESSTRIVIDIA HEALTH, INC.JJX2024-04-03
00021292015107TRUENESSTRIVIDIA HEALTH, INC.JJX2024-04-03
00380740153762AlinityABBOTT LABORATORIESJJX2023-10-14
07613336166338PreciControl beta-Amyloid (1-42) IIRoche Diagnostics GmbHJJX2022-12-13
07613336180860CalCheck beta-Amyloid (1-42) IIRoche Diagnostics GmbHJJX2022-12-13
10673486000719TECO DIAGNOSTICSTECO DIAGNOSTICSJJX2022-08-09
00021292008420TRUE FOCUSTRIVIDIA HEALTH, INC.JJX2021-02-26
00021292008437TRUE FOCUSTRIVIDIA HEALTH, INC.JJX2021-02-26
00021292008444TRUE FOCUSTRIVIDIA HEALTH, INC.JJX2021-02-26
00021292008369TRUEcontrolTRIVIDIA HEALTH, INC.JJX2021-01-29
00021292008383TRUEcontrolTRIVIDIA HEALTH, INC.JJX2021-01-29
14987481164441uTASWako AFP-L3 Control LFUJIFILM WAKO PURE CHEMICAL CORPORATIONJJX2020-10-23
14987481164458uTASWako AFP-L3 Control HFUJIFILM WAKO PURE CHEMICAL CORPORATIONJJX2020-10-23
14987481164489uTASWako DCP Control LFUJIFILM WAKO PURE CHEMICAL CORPORATIONJJX2020-10-23
14987481164496uTASWako DCP Control HFUJIFILM WAKO PURE CHEMICAL CORPORATIONJJX2020-10-23
00021292008390TRUE METRIXTRIVIDIA HEALTH, INC.JJX2020-10-21
00021292008406TRUE METRIXTRIVIDIA HEALTH, INC.JJX2020-10-21