FDA.reportPublic FDA data

AIA-PACK CEA Sample Diluting Solution

Primary DI
04560189211780
Brand
AIA-PACK CEA Sample Diluting Solution
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
DHXSystem, Test, Carcinoembryonic Antigen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DHXSystem, Test, Carcinoembryonic AntigenImmunology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04560189211780PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04560189211780045601892117804560189211780

GMDN Terms#

Term, Definition table
TermDefinition
Carcinoembryonic antigen (CEA) IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of carcinoembryonic antigen (CEA) 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
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
20758750034304VITROSORTHO CLINICAL DIAGNOSTICSDHX2024-01-20
00630414294131Atellica IM CEASiemens Healthcare Diagnostics Inc.DHX2020-05-31
14560189212241AIA-PACK CEA Calibration Verification Test SetTOSOH CORPORATIONDHX2019-07-25
00816870020532Monobind AccuBind CEA ELISA Kit - 96 WellsMONOBIND, INC.DHX2019-02-11
00816870020549Monobind AccuBind CEA ELISA Kit - 192 WellsMONOBIND, INC.DHX2019-02-11
00816870020556Monobind AccuBind CEA Next Generation ELISA Kit - 96 WellsMONOBIND, INC.DHX2019-02-11
00816870020563Monobind AccuBind CEA Next Generation ELISA Kit - 192 WellsMONOBIND, INC.DHX2019-02-11
00816870022215Monobind AccuLite CEA CLIA Kit - 96 WellsMONOBIND, INC.DHX2019-02-11
00816870022222Monobind AccuLite CEA CLIA Kit - 192 WellsMONOBIND, INC.DHX2019-02-11
00816870022239Monobind AccuLite CEA Next Generation CLIA Kit - 96 WellsMONOBIND, INC.DHX2019-02-11
00816870022246Monobind AccuLite CEA Next Generation CLIA Kit - 192 WellsMONOBIND, INC.DHX2019-02-11
00380740130831AlinityAbbott Ireland DiagnosticsDHX2018-12-31
00380740130848AlinityAbbott Ireland DiagnosticsDHX2018-12-31
00380740130855AlinityAbbott Ireland DiagnosticsDHX2018-12-31
00380740130862AlinityAbbott Ireland DiagnosticsDHX2018-12-31
00630414598505Atellica IM CEASiemens Healthcare Diagnostics Inc.DHX2018-02-06
00630414598536Atellica IM CEA MCMSiemens Healthcare Diagnostics Inc.DHX2018-02-06
00630414598529Atellica IM CEA DILSiemens Healthcare Diagnostics Inc.DHX2017-12-27
00630414598512Atellica IM CEASiemens Healthcare Diagnostics Inc.DHX2017-12-22
14560189210780ST AIA-PACK CEATOSOH CORPORATIONDHX2016-09-24
00842768019920Dimension Vista® Flex® reagent cartridge CEASiemens Healthcare Diagnostics Inc.DHX2016-09-24
00630414126302ADVIA Centaur® CEA MCMSiemens Healthcare Diagnostics Inc.DHX2016-09-24
00630414175317ADVIA Centaur® CEA DiluentSiemens Healthcare Diagnostics Inc.DHX2016-09-24
00630414177304ADVIA Centaur® CEASiemens Healthcare Diagnostics Inc.DHX2016-09-24
00630414177311ADVIA Centaur® CEASiemens Healthcare Diagnostics Inc.DHX2016-09-24
00630414204741ADVIA Centaur® CEASiemens Healthcare Diagnostics Inc.DHX2016-09-24
00630414953625IMMULITE®/IMMULITE® 1000 Systems CEA CEA Sample DiluentSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDDHX2016-09-24
00630414961118IMMULITE® 2000 Systems CEASIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDDHX2016-09-24
00630414961125IMMULITE® 2000 Systems CEASIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDDHX2016-09-24
00630414963693IMMULITE®/IMMULITE® 1000 Systems CEASIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDDHX2016-09-24