FDA.reportPublic FDA data

VITROS

Primary DI
10758750032945
Brand
VITROS
Company
ORTHO CLINICAL DIAGNOSTICS
Model
6905561
Catalog number
6905561
Device description
VITROS Immunodiagnostic Products BRAHMS PCT Range Verifiers
Published
2020-05-16
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
PMTDevice to detect and measure procalcitonin (PCT) in human clinical specimens

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20758750032942PackageGS130In Commercial Distribution
10758750032945PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2075875003294220758750032942
1075875003294510758750032945

GMDN Terms#

Term, Definition table
TermDefinition
Procalcitonin (PCT) IVD, controlA material which is used to verify the performance of an assay intended to be used for the quantitative measurement of procalcitonin (PCT) in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-20 Degrees Celsius-20 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
215865786
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10758750033287VITROS619773561977352020-05-16
10758750033294VITROS619557561955752020-05-16
10758750032891VITROS690004069000402025-12-30
10758750033522VITROS691223269122322025-12-30
10758750033539VITROS691223369122332025-12-30
10758750008322VITROS100940610094062020-04-08
10758750002061VITROS680215668021562015-12-22
10758750002504VITROS680230168023012015-12-22
10758750035366VITROS619945461994542025-05-20
10758750035373VITROS619945561994552025-05-20
10758750035380VITROS619945661994562025-05-20
20758750035363VITROS619945461994542025-05-20
20758750035370VITROS619945561994552025-05-20
20758750035387VITROS619945661994562025-05-20
10758750000203VITROS189683618968362016-08-26
10758750002801VITROS680245468024542014-10-22
10758750035465VITROS617444261744422023-11-22
10758750034420VITROS619996161999612021-11-08
10758750033355VITROS619991961999192021-03-22
10758750033362VITROS619992061999202021-03-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
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 GmbHPMT2016-08-17
04260157633223B.R.A.H.M.S KRYPTOR compact SOLUTION 2 B.R.A.H.M.S GmbHPMT2016-08-17
04260157633230B.R.A.H.M.S KRYPTOR compact SOLUTION 3 B.R.A.H.M.S GmbHPMT2016-08-17
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 GmbHPMT2016-08-17
04260157638983B.R.A.H.M.S KRYPTOR compact DILCUPB.R.A.H.M.S GmbHPMT2016-08-17
04260157638990B.R.A.H.M.S KRYPTOR BUFFERB.R.A.H.M.S GmbHPMT2016-08-17