FDA.reportPublic FDA data

AIA-PACK RBC FOLATE

Primary DI
14560189212005
Brand
AIA-PACK RBC FOLATE
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
CGNAcid, Folic, Radioimmunoassay

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CGNAcid, Folic, RadioimmunoassayClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14560189212005PrimaryGS10
04560189212008Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1456018921200514560189212005
04560189212008045601892120084560189212008

GMDN Terms#

Term, Definition table
TermDefinition
Folate (vitamin B9) IVD, kit, radioimmunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of folate (vitamin B9) in a clinical specimen, using a radioimmunoassay method.

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
10
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
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
00630414293653Atellica IM FolSiemens Healthcare Diagnostics Inc.CGN2020-05-31
00380740136567AlinityABBOTT IRELANDCGN2019-02-12
00816870020327Monobind AccuBind Folate ELISA Kit - 96 WellsMONOBIND, INC.CGN2019-02-11
00816870020334Monobind AccuBind Folate ELISA Kit - 192 WellsMONOBIND, INC.CGN2019-02-11
00816870022000Monobind AccuLite Folate CLIA Kit - 96 WellsMONOBIND, INC.CGN2019-02-11
00816870022017Monobind AccuLite Folate CLIA Kit -192 WellsMONOBIND, INC.CGN2019-02-11
00630414469454ADVIA Centaur® FOL (25-pack) ¿ RefSiemens Healthcare Diagnostics Inc.CGN2018-12-01
00380740130923AlinityABBOTT IRELANDCGN2018-11-12
00380740136550AlinityABBOTT IRELANDCGN2018-11-12
00630414597690Atellica™ IM RBC FOLSiemens Healthcare Diagnostics Inc.CGN2018-06-05
00630414598963Atellica™ IM FolSiemens Healthcare Diagnostics Inc.CGN2018-06-05
00630414598970Atellica™ IM FolSiemens Healthcare Diagnostics Inc.CGN2018-06-05
00630414598987Atellica™ IM Fol DILSiemens Healthcare Diagnostics Inc.CGN2018-06-05
00630414598994Atellica™ IM Fol MCMSiemens Healthcare Diagnostics Inc.CGN2018-06-05
00630414599007Atellica™ IM Fol DTT/Releasing AgentSiemens Healthcare Diagnostics Inc.CGN2018-06-05
00817830022597SimulTRAC-SNB Vitamin B12/Folate 125I RIA KitMP BIOMEDICALS, LLCCGN2017-01-09
00817830022603SimulTRAC-S Vitamin B12/Folate 125I RIA KitMP BIOMEDICALS, LLCCGN2017-01-09
00817830022542SimulTRAC-S Vitamin B12/Folate 125I RIA KitMP BIOMEDICALS, LLCCGN2016-10-20
14560189211916AIA-PACK FolateTOSOH CORPORATIONCGN2016-09-24
04560189211926AIA-PACK Folate Calibrator SetTOSOH CORPORATIONCGN2016-09-24
04560189211933AIA-PACK Folate Pretreatment SetTOSOH CORPORATIONCGN2016-09-24
04560189211940AIA-PACK Floate Sample Diluting SolutionTOSOH CORPORATIONCGN2016-09-24
04560189212015AIA-PACK RBC FOLATE CALIBRATOR SETTOSOH CORPORATIONCGN2016-09-24
04560189212022AIA-PACK RBC FOLATE HEMOLYZING REAGENT SETTOSOH CORPORATIONCGN2016-09-24
04560189212039AIA-PACK RBC FOLATE PRETREATMENT SETTOSOH CORPORATIONCGN2016-09-24
04560189212046AIA-PACK RBC FOLATE SAMPLE DILUTING SOLUTIONTOSOH CORPORATIONCGN2016-09-24
00842768016653Dimension Vista® Flex® reagent cartridge FOLSiemens Healthcare Diagnostics Inc.CGN2016-09-24
00630414204192ADVIA Centaur® FOLSiemens Healthcare Diagnostics Inc.CGN2016-09-24
00630414208671ADVIA Centaur® FOL MCMSiemens Healthcare Diagnostics Inc.CGN2016-09-24
00630414450940ADVIA Centaur® FOLSiemens Healthcare Diagnostics Inc.CGN2016-09-24