FDA.reportPublic FDA data

IMMULITE®/IMMULITE® 1000 Systems FER Ferritin Sample Diluent

Primary DI
00630414953748
Brand
IMMULITE®/IMMULITE® 1000 Systems FER Ferritin Sample Diluent
Company
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
Model
10387025
Catalog number
LFEZ
Device description
Ferritin Sample Diluent - IMMULITE - 1x25mL
Published
2016-09-24
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
JMGRadioimmunoassay (two-site solid phase), ferritin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JMGRadioimmunoassay (Two-Site Solid Phase), FerritinImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K925848000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K925848000IMMULITE FERRITINDiagnostic Products Corp.1993-01-13JMG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414953748PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414953748006304149537486304149537480630414953748

GMDN Terms#

Term, Definition table
TermDefinition
Buffered sample diluent IVD, automated/semi-automated systemA buffered diluent solution intended to be used as a consumable reagent on-board an automated or semi-automated instrument during the processing, staining and/or testing of clinical laboratory specimens. Some types may, in addition be used for manual procedures.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
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
15099590772840Access FerritinBeckman Coulter, Inc.JMG2024-04-05
00842768000119Dimension® Sample DiluentSiemens Healthcare Diagnostics Inc.JMG2020-09-24
00842768013768Dimension® Reagent Probe CleanerSiemens Healthcare Diagnostics Inc.JMG2020-09-24
00842768013775Dimension® Sample Probe CleanerSiemens Healthcare Diagnostics Inc.JMG2020-09-24
00842768013782Dimension® IMT Probe CleanerSiemens Healthcare Diagnostics Inc.JMG2020-09-24
00842768014277Dimension® Chemistry WashSiemens Healthcare Diagnostics Inc.JMG2020-09-24
00816870020303Ferritin AccuBind ELISA Test System - 96 WellsMONOBIND, INC.JMG2019-02-11
00816870020310Ferritin AccuBind ELISA Test System - 192 WellsMONOBIND, INC.JMG2019-02-11
00816870021980Ferritin AccuLite CLIA Test System - 96 WellsMONOBIND, INC.JMG2019-02-11
00816870021997Ferritin AccuLite CLIA Test System - 192 WellsMONOBIND, INC.JMG2019-02-11
00842768013928Dimension® Reaction VesselsSiemens Healthcare Diagnostics Inc.JMG2018-09-24
04015630939688Elecsys FerritinRoche Diagnostics GmbHJMG2017-04-21
00842768013867Dimension® Flex® reagent cartridge FERRSiemens Healthcare Diagnostics Inc.JMG2016-09-24
00630414961460IMMULITE® 2000 Systems FER FerritinSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJMG2016-09-24
00630414961477IMMULITE® 2000 Systems FER FerritinSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJMG2016-09-24
00630414963976IMMULITE®/IMMULITE® 1000 Systems FER FerritinSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJMG2016-09-24
04015630920242Elecsys Ferritin CalSetRoche Diagnostics GmbHJMG2016-09-20
04015630938940Elecsys FerritinRoche Diagnostics GmbHJMG2016-09-20
04015630938957Elecsys FerritinRoche Diagnostics GmbHJMG2016-09-20
15099590575045Access Ferritin CalibratorsBeckman Coulter, Inc.JMG2016-09-09
15099590575052Access FerritinBeckman Coulter, Inc.JMG2016-09-09