FDA.report

Access TPO Antibody

Primary DI
15099590201623
Brand
Access TPO Antibody
Company
Beckman Coulter, Inc.
Model
A12985
Catalog number
A12985
Device description
The Access TPO Antibody assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of thyroperoxidase antibody
Published
2016-09-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
JZOSystem, Test, Thyroid Autoantibody

Product Code Classifications

CodeDeviceSpecialtyClass
JZOSystem, Test, Thyroid AutoantibodyImmunology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
15099590201623PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1509959020162315099590201623

GMDN Terms

TermDefinition
Thyroglobulin/Thyroid peroxidase antibody (anti-TPO/Microsomal antibody) IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to both thyroglobulin and thyroid peroxidase (anti-TPO; also known as anti-microsomal antibody) in a clinical specimen, using an enzyme immunoassay (EIA) method.

Sterilization Methods

Method

Regulatory Flags

DUNS number
008254708
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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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