FDA.reportPublic FDA data

ST AIA-PACK FER Calibrator Set

Primary DI
04560189211469
Brand
ST AIA-PACK FER Calibrator Set
Company
TOSOH CORPORATION
Model
N/A
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DBFFerritin, Antigen, Antiserum, Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DBFFerritin, Antigen, Antiserum, ControlImmunology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04560189211469PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04560189211469045601892114694560189211469

GMDN Terms#

Term, Definition table
TermDefinition
Ferritin IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of ferritin in a clinical specimen.

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
614-317-1909Levent.durukan@tosoh.com
650-615-8134Dave.Wurtz@tosoh.com

Regulatory Flags#

DUNS number
690571724
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04560189213418ST AIA-PACK PROG II CALIBRATOR SETN/A2026-02-02
04560189210172ST AIA-PACK 27.29N/A2026-02-02
04560189283923Hemoglobin A1c Control SetN/A2026-01-05
04562185400571HbA1c Diluting SolutionN/A2026-01-05
04562185403060HbA1c Calibrator Set (S)N/A2026-01-05
04562185404920Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01HLC-723GR012026-01-05
0456218540493790 Sample Loader GR-90SL2026-01-05
04562185404944290 Sample LoaderGR-290SL2026-01-05
04562185405255TSKgel GR01 HbA1c ColumnN/A2026-01-05
14562185405269GR01 HbA1c Elution Buffer No. 1N/A2026-01-05
14562185405276GR01 HbA1c Elution Buffer No. 2N/A2026-01-05
14562185405283GR01 HbA1c Elution Buffer No. 3N/A2026-01-05
04562185406207Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 LAHLC-723GR01LA2026-01-05
24560189216321CL AIA-PACK Prolactin II TEST CUPN/A2025-09-01
24560189216338CL AIA-PACK Prolactin II ADJUSTER SETN/A2025-09-01
24560189216628CL AIA-PACK hs-E2 TEST CUPN/A2025-09-01
24560189216635CL AIA-PACK hs-E2 ADJUSTER SETN/A2025-09-01
24562185395390CL AIA-PACK SAMPLE DILUTING REAGENT AN/A2025-09-01
24562185395444CL AIA-PACK T3 TEST CUPN/A2025-09-01
24562185395451CL AIA-PACK T3 ADJUSTER SETN/A2025-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414294162Atellica IM FerSiemens Healthcare Diagnostics Inc.DBF2020-05-31
03610230007327Yumizen C1200 FerritinHORIBA ABX SASDBF2020-05-06
07613336121238Tina-quant Ferritin Gen.4Roche Diagnostics GmbHDBF2020-03-05
00850392007251BioCheck Human Ferritin EIA Test KitBIOCHECK, INC.DBF2019-10-08
14560189212258AIA-PACK FER Calibration Verification Test SetTOSOH CORPORATIONDBF2019-07-25
08600000686017Spectro Ferritin MTRamco Laboratories, Inc.DBF2019-03-23
00840239018724Ferritin ELISADRG International IncDBF2019-03-20
00380740131470AlinityABBOTT IRELANDDBF2018-07-31
00380740131487AlinityABBOTT IRELANDDBF2018-07-31
00630414598925Atellica IM FerSiemens Healthcare Diagnostics Inc.DBF2018-02-06
00630414598932Atellica IM FerSiemens Healthcare Diagnostics Inc.DBF2018-02-06
B24225FERHUE010Ferritin ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.DBF2017-08-03
14560189210483ST AIA-PACK FERTOSOH CORPORATIONDBF2016-09-24
15099590011901AUBeckman Coulter, Inc.DBF2016-09-24
B1761380Antiserum to Human FerritinKENT LABORATORIES INCDBF2016-09-24
04560189211452AIA-PACK FER Sample Diluting SolutionTOSOH CORPORATIONDBF2016-09-24
05055273203073FERRRANDOX LABORATORIES LIMITEDDBF2016-09-24
05055273203080FERRRANDOX LABORATORIES LIMITEDDBF2016-09-24
05055273203097FERRRANDOX LABORATORIES LIMITEDDBF2016-09-24
00842768008085N Latex FerritinSiemens Healthcare Diagnostics Products GmbHDBF2016-09-24
00842768015182Dimension Vista® Flex® reagent cartridge FERRSiemens Healthcare Diagnostics Inc.DBF2016-09-24
00857969006167ACEALFA WASSERMANN, INC.DBF2016-09-24
00630414177144ADVIA Centaur® FERSiemens Healthcare Diagnostics Inc.DBF2016-09-24
00630414177151ADVIA Centaur® FERSiemens Healthcare Diagnostics Inc.DBF2016-09-24
00630414204703ADVIA Centaur® FERSiemens Healthcare Diagnostics Inc.DBF2016-09-24
00630414586069ADVIA® Chemistry FRT Ferritin ReagentsSiemens Healthcare Diagnostics Inc.DBF2016-09-24
00630414590189ADVIA® Chemistry FRT Ferritin ReagentsSiemens Healthcare Diagnostics Inc.DBF2016-09-24
00816426020252K-ASSAY® Ferritin Reagent (L)KAMIYA BIOMEDICAL COMPANY, LLCDBF2016-09-16
00816426020450K-ASSAY® Ferritin ReagentKAMIYA BIOMEDICAL COMPANY, LLCDBF2016-09-16
00380740014070ARCHITECTABBOTT IRELANDDBF2016-09-09