FDA.reportPublic FDA data

Lumipulse G Prolactin Immunoreaction Cartridges

Primary DI
04987270235195
Brand
Lumipulse G Prolactin Immunoreaction Cartridges
Company
FUJIREBIO INC.
Model
235195
Published
2017-10-18
Public version status
Update
Distribution status
Not 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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K163544000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163544000Lumipulse G ProlactinFujirebio Diagnostics,Inc.2017-01-12JIT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04987270235195PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04987270235195049872702351954987270235195

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature2 Degrees Celsius10 Degrees Celsius
Special Storage Condition, Specify00Right side up with care; no vibration
Storage Environment Temperature2 Degrees Celsius10 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
610-240-3800customersupport@fdi.com

Regulatory Flags#

DUNS number
710873907
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04987270235058Lumipulse G BRAHMS PCT Immunoreaction Cartridges2350582018-04-02
04987270235584Lumipulse Infectious Diseases Controls2355842025-07-31
04987270230466Lumipulse G Dilution Cartridges2304662019-12-27
04987270234440Soda Lime for LUMIPULSE System2344402020-01-10
04987270235447Lumipulse G B-Amyloid 1-42-N Plasma2354472025-01-06
04987270235454Lumipulse G B-Amyloid 1-42-N Plasma Calibrator2354542025-01-06
04987270235485Lumipulse G B-Amyloid Controls (Plasma)-N2354852025-01-06
04987270226964Beckman Coulter PK TP System226964PH30002016-09-16
04987270234938Lumipulse G BRAHMS PCT Calibrator Set2349382018-04-02
04987270234945Lumipulse BRAHMS PCT Controls2349452018-04-02
04987270234884Lumipulse G B-Amyloid 1-42 Calibrator Set2348842022-10-31
04987270234891Lumipulse G B-Amyloid 1-40 Calibrator Set2348912022-10-31
04987270234907Lumipulse B-Amyloid Controls2349072022-10-31
04987270231432Lumipulse G B-Amyloid 1-42 Immunoreaction Cartridges2314322022-11-10
04987270231753Lumipulse G B-Amyloid 1-40 Immunoreaction Cartridges2317532022-11-10
04987270231869Lumipulse G SARS-CoV-2 Ag Calibrator Set2318692023-02-01
04987270231876Lumipulse SARS-CoV-2 Ag Controls2318762023-02-01
04987270260340Lumipulse G SARS-CoV-2 Ag Immunoreaction Cartridges2603402023-02-01
04987270234259LUMIPULSE G12002342592019-12-27
04987270230190Lumipulse G whole PTH Immunoreaction Cartridges2301902019-12-18

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