FDA.reportPublic FDA data

VITROS

Primary DI
10758750034321
Brand
VITROS
Company
ORTHO CLINICAL DIAGNOSTICS
Model
6199337
Catalog number
6199337
Device description
VITROS Immunodiagnostic Products Prolactin Reagent Pack
Published
2022-10-24
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
CFTRADIOIMMUNOASSAY, PROLACTIN (LACTOGEN)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CFTRadioimmunoassay, Prolactin (Lactogen)Clinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20758750034328PackageGS130In Commercial Distribution
10758750034321PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2075875003432820758750034328
1075875003432110758750034321

GMDN Terms#

Term, Definition table
TermDefinition
Prolactin IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of prolactin in a clinical specimen, using a chemiluminescent immunoassay method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not freeze
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
215865786
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
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
00850049545433AccuDiag™ Prolactin (PRL) ELISADiagnostic Automation, Inc.CFT2026-01-30
14560189216324CL AIA-PACK Prolactin II TEST CUPTOSOH CORPORATIONCFT2025-09-01
24560189216321CL AIA-PACK Prolactin II TEST CUPTOSOH CORPORATIONCFT2025-09-01
04048474012910Prolactin ELISADRG Instruments Gesellschaft mit beschränkter HaftungCFT2024-11-22
07613336218426Elecsys Prolactin IIRoche Diagnostics GmbHCFT2024-10-08
04048474053692ProlactinDRG Instruments Gesellschaft mit beschränkter HaftungCFT2023-09-01
00840239053695ProlactinDRG International IncCFT2023-08-26
00840239012913Prolactin ELISADRG International IncCFT2023-08-23
B652IB59110Prolactin ELISAIBL AmericaCFT2023-06-08
B24220PROHUE010Prolactin ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.CFT2023-02-22
B261CANPRL41000DBC Prolactin ELISADiagnostics Biochem Canada IncCFT2022-11-10
06925912718772iFlash-ProlactinShenzhen YHLO Biotech Co., Ltd.CFT2022-10-26
15099590232269ACCESS PROLACTIN CALIBRATORSBeckman Coulter, Inc.CFT2021-09-03
15099590575229ACCESS PROLACTINBeckman Coulter, Inc.CFT2021-09-03
00404847412918Prolactin ELISADRG Instruments Gesellschaft mit beschränkter HaftungCFT2021-06-07
00404847453690ProlactinDRG Instruments Gesellschaft mit beschränkter HaftungCFT2021-06-07
00840239017864Prolactin ELISADRG International IncCFT2021-06-07
00630414167497IMMULITE 2000 Prolactin Kit Domestic 200TSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCFT2020-09-24
00630414167503IMMULITE 2000 Prolactin Kit Domestic 600TSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCFT2020-09-24
00630414177267ADVIA Centaur® PRLSiemens Healthcare Diagnostics Inc.CFT2020-09-24
00630414177274ADVIA Centaur® PRLSiemens Healthcare Diagnostics Inc.CFT2020-09-24
00630414204604ADVIA Centaur® Prolactin (PRL)Siemens Healthcare Diagnostics Inc.CFT2020-09-24
00630414599731Atellica IM PRLSiemens Healthcare Diagnostics Inc.CFT2020-09-24
00630414599748Atellica IM PRLSiemens Healthcare Diagnostics Inc.CFT2020-09-24
00630414954172IMMULITE®/IMMULITE® 1000 Systems PRL Prolactin Sample DiluentSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCFT2020-09-24
00630414961934IMMULITE® 2000 Systems PRL ProlactinSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCFT2020-09-24
00630414961941IMMULITE® 2000 Systems PRL ProlactinSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCFT2020-09-24
00842768026454Dimension Vista® Flex® reagent cartridge PRLSiemens Healthcare Diagnostics Inc.CFT2020-09-24
00630414293721Atellica IM PRLSiemens Healthcare Diagnostics Inc.CFT2020-05-31
00630414294223Atellica IM PRLSiemens Healthcare Diagnostics Inc.CFT2020-05-31