FDA.reportPublic FDA data

ARCHITECT

Primary DI
00380740014865
Brand
ARCHITECT
Company
ABBOTT IRELAND
Model
7K76-25
Catalog number
07K7625
Device description
ARCHITECT Prolactin Reagent Kit (100T)
Published
2018-07-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
00380740014865PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740014865003807400148653807400148650380740014865

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
Handling Environment Humidity0 Percent (%) Relative Humidity0 Percent (%) Relative Humidity
Handling Environment Temperature2 Degrees Celsius8 Degrees Celsius
Storage Environment Humidity0 Percent (%) Relative Humidity0 Percent (%) Relative Humidity
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)422-2688xx@xx.xx

Regulatory Flags#

DUNS number
989964119
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
00380740155322Alinity04T992004T99202025-12-19
00380740155339Alinity04T993004T99302025-12-19
00380740155612Alinity04T852004T85202025-12-19
00380740156718ARCHITECT04S892004S89202025-12-19
00380740195236ARCHITECT04T032004T03202025-12-19
00380740195243ARCHITECT04T033004T03302025-12-19
00380740106003ARCHITECT7K78-3507K78352025-12-12
00380740180713Alinity04U002004U00202025-10-24
00380740180720ARCHITECT04T042004T04202025-10-24
00380740204020ARCHITECT04T040104T04012025-10-24
00380740204037Alinity04U000104U00012025-10-24
00380740130572Alinity07P944007P94402020-07-03
00380740014346ARCHITECT7K64-5007K64502016-09-09
00380740155285Alinity04T822004T82202024-08-15
00380740155292Alinity04T823004T82302024-08-15
00380740155346Alinity04U302004U30202024-08-15
00380740155353Alinity04U303004U30302024-08-15
00380740155483ARCHITECT04U452004U45202024-08-15
00380740155490ARCHITECT04U453004U45302024-08-15
00380740155872ARCHITECT04T342004T34202024-08-15

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
10758750034321VITROSORTHO CLINICAL DIAGNOSTICSCFT2022-10-24
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