FDA.report

AIA-PACK CEA Calibration Set

Primary DI
04560189211773
Brand
AIA-PACK CEA Calibration 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
JISCalibrator, Primary

Product Code Classifications

CodeDeviceSpecialtyClass
JISCalibrator, PrimaryClinical Chemistry2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04560189211773PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04560189211773045601892117734560189211773

GMDN Terms

TermDefinition
Carcinoembryonic antigen (CEA) 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 carcinoembryonic antigen (CEA) 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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