FDA.reportPublic FDA data

B.R.A.H.M.S KRYPTOR compact SOLUTION 3

Primary DI
04260157633230
Brand
B.R.A.H.M.S KRYPTOR compact SOLUTION 3
Company
B.R.A.H.M.S GmbH
Model
89983
Published
2016-08-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JZTFluorometer
PMTDevice To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JZTFluorometerImmunology1
PMTDevice To Detect And Measure Procalcitonin (Pct) In Human Clinical SpecimensMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN150009000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN150009000B.R.A.H.M.S PCT sensitive KRYPTORBrahms GmbH2016-02-20PMT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260157633230PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260157633230042601576332304260157633230

GMDN Terms#

Term, Definition table
TermDefinition
Fluorescent immunoassay analyser IVD, laboratory, automatedA stationary mains electricity (AC-powered) laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of chemical and/or biological markers in a clinical specimen. The instrument detects fluorescent markers that result from an immunological reaction between the reagents and the specimen, and typically includes an autosampler, reagent dispenser, light source, filter or monochromator, a fluorescent detection system (fluorometer or spectrofluorometer), data processing and/or data display software. The device operates with minimal technician involvement and complete automation of all procedural steps.

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
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
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
08800026300083Exdia TRF PlusPrecision Biosensor Inc.JZT2022-11-16
00630414238692DM EXL LOCI BRAHMS PCTSiemens Healthcare Diagnostics Inc.PMT2022-11-15
00630414298214DM EXL LOCI BRAHMS PCTSiemens Healthcare Diagnostics Inc.PMT2022-11-15
10758750032938VITROSORTHO CLINICAL DIAGNOSTICSPMT2020-05-16
10758750032945VITROSORTHO CLINICAL DIAGNOSTICSPMT2020-05-16
10758750033287VITROSORTHO CLINICAL DIAGNOSTICSPMT2020-05-16
10758750033294VITROSORTHO CLINICAL DIAGNOSTICSPMT2020-05-16
00380740153953AlinityAbbott Ireland DiagnosticsPMT2019-01-04
00630414246550Atellica IM BRAHMS PCTSiemens Healthcare Diagnostics Inc.PMT2018-10-05
04987270234945Lumipulse BRAHMS PCT ControlsFUJIREBIO INC.PMT2018-04-02
04987270235058Lumipulse G BRAHMS PCT Immunoreaction CartridgesFUJIREBIO INC.PMT2018-04-02
00380740138905ARCHITECTAbbott GmbHPMT2017-08-16
00380740138912ARCHITECTAbbott GmbHPMT2017-08-16
00380740139032ARCHITECTAbbott GmbHPMT2017-08-16
00380740139049ARCHITECTAbbott GmbHPMT2017-08-16
04260157632875B.R.A.H.M.S PCT sensitive KRYPTOR CALB.R.A.H.M.S GmbHPMT2017-08-15
04015630940073Elecsys BRAHMS PCTRoche Diagnostics GmbHPMT2017-04-21
03573026223601VIDAS® B·R·A·H·M·S PCT ™BIOMERIEUX SAPMT2016-09-23
04015630939114Elecsys BRAHMS PCTRoche Diagnostics GmbHPMT2016-09-20
04260157630949B.R.A.H.M.S KRYPTOR compact PLUS B.R.A.H.M.S GmbHPMT2016-08-17
04260157630949B.R.A.H.M.S KRYPTOR compact PLUS B.R.A.H.M.S GmbHJZT2016-08-17
04260157632882B.R.A.H.M.S PCT sensitive KRYPTOR QC B.R.A.H.M.S GmbHPMT2016-08-17
04260157633216B.R.A.H.M.S KRYPTOR compact SOLUTION 1 B.R.A.H.M.S GmbHJZT2016-08-17
04260157633216B.R.A.H.M.S KRYPTOR compact SOLUTION 1 B.R.A.H.M.S GmbHPMT2016-08-17
04260157633223B.R.A.H.M.S KRYPTOR compact SOLUTION 2 B.R.A.H.M.S GmbHJZT2016-08-17
04260157633223B.R.A.H.M.S KRYPTOR compact SOLUTION 2 B.R.A.H.M.S GmbHPMT2016-08-17
04260157633247B.R.A.H.M.S KRYPTOR compact SOLUTION 4B.R.A.H.M.S GmbHJZT2016-08-17
04260157633247B.R.A.H.M.S KRYPTOR compact SOLUTION 4B.R.A.H.M.S GmbHPMT2016-08-17
04260157638259B.R.A.H.M.S PCT sensitive KRYPTOR B.R.A.H.M.S GmbHPMT2016-08-17
04260157638976B.R.A.H.M.S KRYPTOR compact REACTB.R.A.H.M.S GmbHJZT2016-08-17