FDA.report

AIA-PACK 27.29 Calibrator Set

Primary DI
04560189211100
Brand
AIA-PACK 27.29 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

Related Records

Contact Domains

Product Codes

CodeName
MOISystem, Test, Immunological, Antigen, Tumor

Product Code Classifications

CodeDeviceSpecialtyClass
MOISystem, Test, Immunological, Antigen, TumorImmunology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04560189211100PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04560189211100045601892111004560189211100

GMDN Terms

TermDefinition
Cancer antigen 15-3 (CA15-3) 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 cancer antigen 15-3 (CA15-3), a marker commonly associated with breast cancer, in a clinical specimen.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Contacts

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

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Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
04560189210172ST AIA-PACK 27.29TOSOH CORPORATIONMOI2026-02-02
07613336218334Elecsys CA 15-3 IIRoche Diagnostics GmbHMOI2024-07-30
00630414294049Atellica IM BRSiemens Healthcare Diagnostics Inc.MOI2020-05-31
00630414294056Atellica IM BR CalibratorSiemens Healthcare Diagnostics Inc.MOI2020-05-31
00630414294063Atellica IM CA 15-3Siemens Healthcare Diagnostics Inc.MOI2020-05-31
00816870020495Monobind AccuBind CA 15-3 ELISA Kit - 96 WellsMONOBIND, INC.MOI2019-02-11
00816870020501Monobind AccuBind CA 15-3 ELISA Kit - 192 WellsMONOBIND, INC.MOI2019-02-11
00816870022178Monobind AccuLite CA 15-3 CLIA Kit - 96 WellsMONOBIND, INC.MOI2019-02-11
00816870022185Monobind AccuLite CA 15-3 CLIA Kit - 192 WellsMONOBIND, INC.MOI2019-02-11
00380740145316ARCHITECTAbbott GmbH & Co. KGMOI2019-01-21
00380740145323ARCHITECTAbbott GmbH & Co. KGMOI2019-01-21
00380740145330ARCHITECTAbbott GmbH & Co. KGMOI2019-01-21
00380740131432AlinityAbbott GmbH & Co. KGMOI2018-12-31
00380740131449AlinityAbbott GmbH & Co. KGMOI2018-12-31
00630414598055Atellica IM BRSiemens Healthcare Diagnostics Inc.MOI2018-02-06
00630414598123Atellica IM CA 15-3Siemens Healthcare Diagnostics Inc.MOI2018-02-06
00630414598130Atellica IM CA 15-3Siemens Healthcare Diagnostics Inc.MOI2018-02-06
00630414598154Atellica IM CA 15-3 MCMSiemens Healthcare Diagnostics Inc.MOI2018-02-06
00630414598048Atellica IM BRSiemens Healthcare Diagnostics Inc.MOI2017-12-27
00630414598062Atellica IM BR MCMSiemens Healthcare Diagnostics Inc.MOI2017-12-27
00630414598079Atellica IM BR PRESiemens Healthcare Diagnostics Inc.MOI2017-12-27
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04251269200601Back Cushion Flexibility MaquetNoras MRI products GmbHMOI2017-09-06
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