FDA.reportPublic FDA data

Atellica IM FSH

Primary DI
00630414599052
Brand
Atellica IM FSH
Company
Siemens Healthcare Diagnostics Inc.
Model
10995581
Catalog number
10995581
Device description
Follicle Stimulating Hormone (FSH) Atellica IM - RGT 950T
Published
2020-09-24
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
CGJRADIOIMMUNOASSAY, FOLLICLE-STIMULATING HORMONE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CGJRadioimmunoassay, Follicle-Stimulating HormoneClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K904649000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K904649000CIBA CORNING ACS FSH IMMUNOASSAYCiba Corning Diagnostics Corp.1990-11-20CGJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414599052PrimaryGS10
00630414007557Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414599052006304145990526304145990520630414599052
00630414007557006304140075576304140075570630414007557

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store upright, Protect from light
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630414124797ADVIA Centaur® Calibrator D10311569103115692014-09-24
00630414124933ADVIA Centaur® Systems, ACS:180® Systems Calibrator D10311576103115762014-09-24
00630414126319ADVIA Centaur® Systems, ACS 180® Systems AFP MCM10311625103116252014-09-24
00630414177335ADVIA Centaur® AFP10309980103099802014-09-24
00630414238791Atellica IM AFP11202257112022572018-11-14
00630414238807Atellica IM AFP11202258112022582018-11-14
00630414597720Atellica IM AFP MCM10995443109954432018-11-14
00630414279176ADVIA Chemistry UCFP11319151113191512020-03-06
00630414209845ADVIA® Chemistry MG Magnesium Reagents10341119103411192020-09-24
00630414474748ADVIA® Chemistry TIBC Total Iron Binding Capacity Reagents10309071103090712020-09-24
00630414508399ADVIA® Chemistry IP Inorganic Phosphorus Reagents10309503103095032020-09-24
00630414508429ADVIA® Chemistry MG Magnesium Reagents10309506103095062020-09-24
00630414561073ADVIA® Chemistry CHOL_2 Cholesterol_2 Reagent10376501103765012020-09-24
00630414561974ADVIA® Chemistry IRON_2 Iron 2 Reagents10377510103775102020-09-24
00630414279183ADVIA Chemistry UCFP Calibrator11319152113191522020-03-06
00842768013836Dimension Cardiac Troponin-I Flex reagent cartridge10444905104449052016-09-24
00842768013904Dimension Cardiac Troponin-I Flex reagent cartridge10444896104448962016-09-24
00630414008967ADVIA® Chemistry Enzyme 1 Calibrator10916057109160572016-09-24
00630414177328ADVIA Centaur® AFP10309979103099792014-09-24
00630414553153ADVIA® Chemistry (AST_c) AST(GOT) Reagents Concentrated10283343102833432016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850054026705 AccuDiag™ FSH ELISADiagnostic Automation, Inc.CGJ2026-01-27
14562185400318CL AIA-PACK FSH TEST CUPTOSOH CORPORATIONCGJ2025-09-01
04562185400311CL AIA-PACK FSH TEST CUPTOSOH CORPORATIONCGJ2025-09-01
04048474012880FSH ELISADRG Instruments Gesellschaft mit beschränkter HaftungCGJ2024-11-22
07613336217801Elecsys FSHRoche Diagnostics GmbHCGJ2024-08-19
04048474053555FSHDRG Instruments Gesellschaft mit beschränkter HaftungCGJ2023-09-01
04048474040982FSH ELISADRG Instruments Gesellschaft mit beschränkter HaftungCGJ2023-08-31
00840239053558FSHDRG International IncCGJ2023-08-26
00840239012883FSH ELISADRG International IncCGJ2023-08-22
15099590575236Access hFSHBeckman Coulter, Inc.CGJ2023-06-26
B261CANFSH40600DBC Follicle Stimulating Hormone (FSH) ELISADiagnostics Biochem Canada IncCGJ2022-11-15
06925912718499iFlash-FSHShenzhen YHLO Biotech Co., Ltd.CGJ2022-10-26
B512210011One Step Menopausal TestUNIVERSAL MEDITECH INC.CGJ2021-10-15
07613336170373Elecsys FSHRoche Diagnostics GmbHCGJ2021-10-06
07613336170380Elecsys FSHRoche Diagnostics GmbHCGJ2021-10-06
15099590575250Access hFSH CalibratorsBeckman Coulter, Inc.CGJ2021-09-03
00404847412888FSH ELISADRG Instruments Gesellschaft mit beschränkter HaftungCGJ2021-06-07
00840239040985FSH ELISADRG International IncCGJ2021-06-07
B24211FSHHUE010Follicle Stimulating Hormone (FSH) ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.CGJ2020-09-25
00630414126210ADVIA Centaur® FSH MCMSiemens Healthcare Diagnostics Inc.CGJ2020-09-24
00630414167435IMMULITE 2000 FSH Kit Domestic 200TSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCGJ2020-09-24
00630414167442IMMULITE 2000 FSH Kit Domestic 600TSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCGJ2020-09-24
00630414177243ADVIA Centaur® FSHSiemens Healthcare Diagnostics Inc.CGJ2020-09-24
00630414177250ADVIA Centaur® FSHSiemens Healthcare Diagnostics Inc.CGJ2020-09-24
00630414204666ADVIA Centaur® FSHSiemens Healthcare Diagnostics Inc.CGJ2020-09-24
00630414599045Atellica IM FSHSiemens Healthcare Diagnostics Inc.CGJ2020-09-24
00630414599069Atellica IM FSH MCMSiemens Healthcare Diagnostics Inc.CGJ2020-09-24
00630414953779IMMULITE®/IMMULITE® 1000 Systems FSH Sample DiluentSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCGJ2020-09-24
00630414953786IMMULITE® 2000 Systems FSH FSH Sample DiluentSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCGJ2020-09-24
00630414961507IMMULITE® 2000 Systems FSHSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCGJ2020-09-24