FDA.reportPublic FDA data

Atellica IM AFP

Primary DI
00630414238807
Brand
Atellica IM AFP
Company
Siemens Healthcare Diagnostics Inc.
Model
11202258
Catalog number
11202258
Device description
Alpha-Fetoprotein(AFP) - Atellica IM - RGT - 500T
Published
2018-11-14
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
LOKKIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LOKKit, Test, Alpha-Fetoprotein For Neural Tube DefectsUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P930036008
P930036009

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P930036008ADVIA CENTAUR AFP REAGENTS AND CALIBRATORSSiemens Healthcare Diagnostics, Inc.1995-09-29LOK
P930036009ADVIA CENTAUR AFP REAGENTS AND CALIBRATORSSiemens Healthcare Diagnostics, Inc.1995-09-29LOK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414238807PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414238807006304142388076304142388070630414238807

GMDN Terms#

Term, Definition table
TermDefinition
Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of alpha-fetoprotein (AFP) 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, Do not freeze, Resuspend.
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
1
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
15099590744403Access AFPBeckman Coulter, Inc.LOK2025-11-10
00630414293561Atellica IM Calibrator DSiemens Healthcare Diagnostics Inc.LOK2020-05-31
00630414294117Atellica IM Calibrator DSiemens Healthcare Diagnostics Inc.LOK2020-05-31
00380740130794AlinityAbbott Ireland DiagnosticsLOK2019-11-06
00380740130800AlinityAbbott Ireland DiagnosticsLOK2019-11-06
00380740130817AlinityAbbott Ireland DiagnosticsLOK2019-11-06
00380740130824AlinityAbbott Ireland DiagnosticsLOK2019-11-06
00630414238791Atellica IM AFPSiemens Healthcare Diagnostics Inc.LOK2018-11-14
00630414597720Atellica IM AFP MCMSiemens Healthcare Diagnostics Inc.LOK2018-11-14
00630414598369Atellica IM Calibrator DSiemens Healthcare Diagnostics Inc.LOK2017-12-27
00630414598376Atellica IM Calibrator DSiemens Healthcare Diagnostics Inc.LOK2017-12-27
00630414022963ADVIA Centaur® AFPSiemens Healthcare Diagnostics Inc.LOK2016-07-12
00380740112400ARCHITECTAbbott Ireland DiagnosticsLOK2014-12-19
00380740081287ARCHITECTAbbott Ireland DiagnosticsLOK2014-11-18
00380740081294ARCHITECTAbbott Ireland DiagnosticsLOK2014-11-18
00380740081317ARCHITECTAbbott Ireland DiagnosticsLOK2014-11-18
06438147321315AutoDELFIA hAFP KitWallac OyLOK2014-09-24
06438147321322AutoDELFIA hAFP kitWallac OyLOK2014-09-24
00630414124797ADVIA Centaur® Calibrator DSiemens Healthcare Diagnostics Inc.LOK2014-09-24
00630414124933ADVIA Centaur® Systems, ACS:180® Systems Calibrator DSiemens Healthcare Diagnostics Inc.LOK2014-09-24
00630414124940ADVIA Centaur® Systems, ACS:180® Systems Calibrator DSiemens Healthcare Diagnostics Inc.LOK2014-09-24
00630414126319ADVIA Centaur® Systems, ACS 180® Systems AFP MCMSiemens Healthcare Diagnostics Inc.LOK2014-09-24
00630414177328ADVIA Centaur® AFPSiemens Healthcare Diagnostics Inc.LOK2014-09-24
00630414177335ADVIA Centaur® AFPSiemens Healthcare Diagnostics Inc.LOK2014-09-24
00630414953519IMMULITE®/IMMULITE®1000 Systems AF AFP Sample DiluentSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLOK2014-09-24
00630414961033IMMULITE® 2000 Systems AF AFPSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLOK2014-09-24
00630414961040IMMULITE® 2000 Systems AF AFPSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLOK2014-09-24
00630414963594IMMULITE®/IMMULITE®1000 Systems AF AFPSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLOK2014-09-24
H628332111Access AFPBeckman Coulter, Inc.LOK2014-09-16
H628332161Access AFP Sample DiluentBeckman Coulter, Inc.LOK2014-09-16