FDA.reportPublic FDA data

AIA-PACK 25-OH Vitamin D CONTROL SET

Primary DI
04560189213159
Brand
AIA-PACK 25-OH Vitamin D CONTROL 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
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)Clinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04560189213159PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04560189213159045601892131594560189213159

GMDN Terms#

Term, Definition table
TermDefinition
Multiple form 25-hydroxy Vitamin D IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of multiple forms of 25-hydroxy vitamin D 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

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