FDA.report

AIA-PACK CA 125 Calibrator Set

Primary DI
04560189211148
Brand
AIA-PACK CA 125 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
LTKTest, Epithelial Ovarian Tumor-Associated Antigen (Ca125)

Product Code Classifications

CodeDeviceSpecialtyClass
LTKTest, Epithelial Ovarian Tumor-Associated Antigen (Ca125)Immunology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04560189211148PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04560189211148045601892111484560189211148

GMDN Terms

TermDefinition
Cancer antigen 125 (CA125) IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of cancer antigen 125 (CA125), a marker commonly associated with ovarian 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
07613336218327Elecsys CA 125 IIRoche Diagnostics GmbHLTK2024-08-13
10758750034826VITROSORTHO CLINICAL DIAGNOSTICSLTK2023-03-14
10758750034901VITROSORTHO CLINICAL DIAGNOSTICSLTK2023-03-14
00630414294278Atellica IM CA 125IISiemens Healthcare Diagnostics Inc.LTK2020-05-31
00380740131043AlinityAbbott GmbH & Co. KGLTK2019-02-12
00816870020471Monobind AccuBind CA 125 ELISA Kit - 96 WellsMONOBIND, INC.LTK2019-02-11
00816870020488Monobind AccuBind CA 125 ELISA Kit - 192 WellsMONOBIND, INC.LTK2019-02-11
00816870022154Monobind AccuLite CA 125 CLIA Kit - 96 WellsMONOBIND, INC.LTK2019-02-11
00816870022161Monobind AccuLite CA 125 CLIA Kit - 192 WellsMONOBIND, INC.LTK2019-02-11
00380740145361ARCHITECTAbbott GmbH & Co. KGLTK2019-01-21
00380740145378ARCHITECTAbbott GmbH & Co. KGLTK2019-01-21
00380740145385ARCHITECTAbbott GmbH & Co. KGLTK2019-01-21
00380740131050AlinityAbbott GmbH & Co. KGLTK2018-12-31
00630414598116Atellica IM CA 125II MCMSiemens Healthcare Diagnostics Inc.LTK2017-12-27
00630414598086Atellica IM CA 125IISiemens Healthcare Diagnostics Inc.LTK2017-12-22
00630414598093Atellica IM CA 125IISiemens Healthcare Diagnostics Inc.LTK2017-12-22
00630414598109Atellica IM CA 125II CalibratorSiemens Healthcare Diagnostics Inc.LTK2017-12-22
14560189210216ST AIA-PACK CA 125TOSOH CORPORATIONLTK2016-09-24
04560189211131AIA-PACK CA 125 Sample Diluting SolutionTOSOH CORPORATIONLTK2016-09-24
00842768028519Dimension Vista® Flex® reagent cartridge CA125Siemens Healthcare Diagnostics Inc.LTK2016-09-24
00630414461274ADVIA Centaur® CA 125II MCMSiemens Healthcare Diagnostics Inc.LTK2016-09-24
00630414461298ADVIA Centaur® CA 125IISiemens Healthcare Diagnostics Inc.LTK2016-09-24
00630414461304ADVIA Centaur® CA 125 IISiemens Healthcare Diagnostics Inc.LTK2016-09-24
00630414461335ADVIA Centaur® Systems CA 125II CalibratorSiemens Healthcare Diagnostics Inc.LTK2016-09-24
00630414954127IMMULITE®/IMMULITE® 1000 Systems OMM OM-MA Sample DiluentSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLTK2016-09-24
00630414954134IMMULITE® 2000 Systems OM-MA Sample DiluentSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLTK2016-09-24
00630414954219IMMULITE®/IMMULITE® 1000 Systems RTH Rapid TSH Sample DiluentSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLTK2016-09-24
00630414961798IMMULITE® 2000 Systems OV OM-MA (CA125)SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLTK2016-09-24
00630414964331IMMULITE®/IMMULITE® 1000 Systems OV OM-MA (CA 125)SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLTK2016-09-24
04987270234273Lumipulse G CA125II Immunoreaction CartridgesFUJIREBIO INC.LTK2016-09-16