FDA.reportPublic FDA data

B.R.A.H.M.S PlGF plus KRYPTOR

Primary DI
04260157632196
Brand
B.R.A.H.M.S PlGF plus KRYPTOR
Company
B.R.A.H.M.S GmbH
Model
859075N
Published
2023-05-22
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
QWHPrognostic Test For Development Or Progression Of Preeclampsia

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QWHPrognostic Test For Development Or Progression Of PreeclampsiaClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN220027000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN220027000B·R·A·H·M·S sFlt-1/ PlGF KRYPTOR Test SystemBrahms GmbH, Part of Thermo Fisher Scientific2023-05-18QWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260157632196PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260157632196042601576321964260157632196

GMDN Terms#

Term, Definition table
TermDefinition
Placental growth factor (PLGF) IVD, kit, fluorescent immunoassayA collection of reagents and other associated materials intended to be used for the quantitative measurement of placental growth factor (PLGF) in a clinical specimen, using a fluorescent immunoassay method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
343844205
Device count
1
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
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
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
07613336172094Elecsys sFlT-1Roche Diagnostics GmbHQWH2025-04-07
07613336172124Elecsys PlGFRoche Diagnostics GmbHQWH2025-04-07
07613336230671Elecsys sFlT-1Roche Diagnostics GmbHQWH2025-04-07
07613336230756Elecsys PlGFRoche Diagnostics GmbHQWH2025-04-07
04260157632158B.R.A.H.M.S sFlt-1 KRYPTORB.R.A.H.M.S GmbHQWH2023-05-22