FDA.reportPublic FDA data

Atellica IM PRL

Primary DI
00630414293721
Brand
Atellica IM PRL
Company
Siemens Healthcare Diagnostics Inc.
Model
11206258
Catalog number
11206258
Device description
Prolactin (PRL) - Atellica IM - RGT 250
Published
2020-05-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00630414293721PrimaryGS10
00630414294223Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414293721006304142937216304142937210630414293721
00630414294223006304142942236304142942230630414294223

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, Specify00Store upright, Protect from light
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(877)229-3711CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
064608573
Device count
5
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630414517681ADVIA® Chemistry ASO_2 Anti-Streptolysin-O_2 Reagents1031820830554832020-09-24
00842768016912Dimension® PBNP Calibrator10445008RC423A2016-09-24
00630414498942ADVIA® Chemistry ACET Acetaminophen Reagents1032738179891382016-09-24
00630414568768ADVIA® Chemistry BENZ_2 Benzodiazepine_2 Reagents10378760103787602016-09-24
00630414611075Atellica CH Crea311537215115372152026-05-08
00630414653259Atellica CH Crea311537567115375672026-05-08
00630414618456ADVIA CENTAUR ELF MCM SET11208709112087092023-03-15
00630414506005ADVIA® Chemistry HAPT Haptoglobin Reagents103141648310082016-09-24
00630414595795Atellica CH ECre_211097533110975332017-12-22
00842768015281Dimension Vista® Flex® reagent cartridge LIDO10445132K41132016-09-24
00630414291338ADVIA Centaur Cytokeratin Fragment 21-1 (CYFRA)11354590113545902026-04-16
00630414291345Atellica IM CYFRA 21-111354591113545912026-04-16
00630414292779Siemens Healthineers CYFRA 21-1 MCM11536187115361872026-04-16
00630414292786Atellica IM CYFRA 21-1 MCM11536188115361882026-04-16
00630414611693ADVIA Centaur Cytokeratin Fragment 21-1 Calibrator (CYFRA CAL)11553956115539562026-04-16
00630414622804Atellica IM CYFRA21-1 Calibrator11553957115539572026-04-16
00630414654041Atellica CH Ca11645759116457592026-04-08
00630414654102Atellica CH ALP_2c11645758116457582026-04-08
00630414654133Atellica CH UA11645765116457652026-04-08
00630414293622Atellica IM DHEAS11206197112061972020-05-31

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
00630414294223Atellica IM PRLSiemens Healthcare Diagnostics Inc.CFT2020-05-31