FDA.report

Prolactin ELISA

Primary DI
00840239012913
Brand
Prolactin ELISA
Company
DRG International Inc
Model
EIA-1291
Catalog number
EIA-1291
Device description
The DRG Prolactin ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of Prolactin in serum.
Published
2023-08-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
CFTRadioimmunoassay, Prolactin (Lactogen)

Product Code Classifications

CodeDeviceSpecialtyClass
CFTRadioimmunoassay, Prolactin (Lactogen)Clinical Chemistry1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840239012913PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840239012913008402390129138402390129130840239012913

GMDN Terms

TermDefinition
Prolactin IVD, kit, enzyme immunoassay (EIA)A 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 an enzyme immunoassay (EIA) method.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
9735647555corpoffice@drg-international.com

Regulatory Flags

DUNS number
075150847
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00840239035776Anti-Sm ELISAEIA-3577EIA-35772023-08-25
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00840239035813Anti-Jo-1 ELISAEIA-3581EIA-35812023-08-25
00840239035837Rheumatoid Factor Screen ELISAEIA-3583EIA-35832023-08-25
00840239035844RF IgG (Rheumatoid Factor) ELISAEIA-3584EIA-35842023-08-25
00840239035851Rheumatoid Factor IgM ELISAEIA-3585EIA-35852023-08-25
00840239035868Rheumatoid Factor IgA ELISAEIA-3586EIA-35862023-08-25
00840239035875Anti-Cardiolipin IgG/IgM ELISAEIA-3587EIA-35872023-08-25

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00850049545433AccuDiag™ Prolactin (PRL) ELISADiagnostic Automation, Inc.CFT2026-01-30
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
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
00630414294223Atellica IM PRLSiemens Healthcare Diagnostics Inc.CFT2020-05-31
04015630921546Elecsys Prolactin IIRoche Diagnostics GmbHCFT2020-05-14
10758750000111VITROSORTHO CLINICAL DIAGNOSTICSCFT2020-04-01