FDA.reportPublic FDA data

Anti TPO Ab ELISA

Primary DI
00840239035615
Brand
Anti TPO Ab ELISA
Company
DRG International Inc
Model
EIA-3561
Catalog number
EIA-3561
Device description
Anti TPO Ab ELISA is a test system for the quantitative measurement of IgG class autoantibodies against thyroid peroxidase (TPO) in human serum or plasma.
Published
2023-08-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JZOSystem, Test, Thyroid Autoantibody

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JZOSystem, Test, Thyroid AutoantibodyImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K952129000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K952129000ORGENTEC ANTI-TPO ELISAAmerican Laboratory Products Co., Ltd.1995-06-20JZO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840239035615PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840239035615008402390356158402390356150840239035615

GMDN Terms#

Term, Definition table
TermDefinition
Multiple thyroid autoantibody 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 the thyroid gland and/or specific products of thyroid gland metabolism in a clinical specimen, using an enzyme immunoassay (EIA) method. This test detects autoantibodies directed at antigens such as thyroid gland tissue, thyroglobulin, and thyroid peroxidase (TPO) [known as anti-microsomal antibody] to aid in the diagnosis of autoimmune thyroid diseases such as autoimmune thyroiditis (Hashimoto’s disease) and Graves’ disease.

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
9735647555corpoffice@drg-international.com

Regulatory Flags#

DUNS number
075150847
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

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