FDA.reportPublic FDA data

IMMULITE® 2000 Systems AF AFP

Primary DI
00630414961033
Brand
IMMULITE® 2000 Systems AF AFP
Company
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
Model
10381187
Catalog number
L2KAP2
Device description
AF AFP Kit 200 Test
Published
2014-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
P010007001
P010007002
P010007004
P010007005

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P010007001IMMULITE/IMMULITE 1000 AFP AND IMMULITE 2000/IMMULITE 2500 AFPSiemens Healthcare Diagnostics, Inc.2001-11-09LOK
P010007002IMMULITE/IMMULITE 1000 AFP AND IMMULITE 2000/IMMULITE 2500 AFPSiemens Healthcare Diagnostics, Inc.2001-11-09LOK
P010007004IMMULITE/IMMULITE 1000 AFP AND IMMULITE 2000/IMMULITE 2500 AFPSiemens Healthcare Diagnostics, Inc.2001-11-09LOK
P010007005IMMULITE/IMMULITE 1000 AFP AND IMMULITE 2000/IMMULITE 2500 AFPSiemens Healthcare Diagnostics, Inc.2001-11-09LOK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414961033PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414961033006304149610336304149610330630414961033

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, Specify00Protect 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
296822794
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630414965017IMMULITE®/IMMULITE® 1000 Systems SUBS10385394LSUBX2020-09-24
00630414961125IMMULITE® 2000 Systems CEA10380995L2KCE62016-09-24
00630414964980IMMULITE®/IMMULITE® 1000 Systems RPT Turbo Intact PTH10381430LSKPTZ2016-09-24
00630414970110IMMULITE®/IMMULITE® 1000 Systems T4 Total T410381635LKT452016-09-24
00630414972923IMMULITE®2000 Systems Diluent Tube Caps10385211L2ZC2020-09-24
00630414965734IMMULITE® 2000 Systems Allergen Tube Caps10282837L2ATC2020-09-24
00630414965741IMMULITE® 2000 Systems Allergen Tubes10282849L2ATS22020-09-24
00630414973159IMMULITE® 2000 Systems Diluent Tubes10385210L2ZT2020-09-24
00630414974064IMMULITE® 2000 Systems Microsampling Tube Caps10385205LSMC2020-09-24
00630414954547IMMULITE® 2000 Systems Reaction Tubes10385206LRXT2016-09-24
00630414973937IMMULITE® 2000 Systems Microsampling Tubes10385207LMST2016-09-24
00630414982403IMMULITE® 2000 XPi Sample Nesting Cups103741789052882016-09-24
00630414982410IMMULITE® 2000 Xpi Sample Nesting Cups103741799052892016-09-24
00630414961538IMMULITE® 2000 Systems IGF-110381448L2KGF22020-09-24
00630414245317Atellica IM Anti-Thyroglobulin II (aTgII)11201759112017592026-02-04
00630414245324Atellica IM Anti-Thyroglobulin II (aTgII)11201761112017612026-02-04
00630414245331Atellica IM aTgII Quality Control (aTgII QC)11201752112017522026-02-04
00630414245348Atellica IM aTgII Master Curve Material (aTgII MCM)11201751112017512026-02-04
00630414245355ADVIA Centaur Anti-Thyroglobulin II (aTgII)11201758112017582026-02-04
00630414245362ADVIA Centaur Anti-Thyroglobulin II (aTgII)11201760112017602026-02-04

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
00630414238807Atellica 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
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