FDA.reportPublic FDA data

EL-anti-TPO

Primary DI
00854473003255
Brand
EL-anti-TPO
Company
THERA-TEST LABORATORIES, INC
Model
104-119
Catalog number
104-119
Device description
ANTI-THYROPEROXIDASE (TPO) ANTIBODY ELISA TEST KIT, 192 TESTS
Published
2016-07-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K090760000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090760000THERATEST EL-ANTI-TPO AND THERATEST EL-ANTI-THYROGLOBULIN, MODEL 104-119, 103-120Theratest Laboratories, Inc.2009-09-03JZO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00854473003255PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854473003255008544730032558544730032550854473003255

GMDN Terms#

Term, Definition table
TermDefinition
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 thyroid peroxidase (anti-TPO); also known as anti-microsomal antibody, in a clinical specimen, using an enzyme immunoassay (EIA) method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
194336954
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00854473003347EL-ANA PROFILES: ANA/8103-005103-0052023-07-06
00854473003354EL-ANA PROFILES: ANA/6101-005101-0052023-07-06
00854473003323EL-Anti-SARS-CoV-2 IgM104-129104-1292020-05-19
00854473003330EL-Anti-SARS-CoV-2 IgG104-130104-1302020-05-19
00854473003316EL-Anti-SARS-CoV-2104-128104-1282020-05-04
00854473003002EL-ANA PROFILES: EL-ANAscr100-002100-0022016-08-15
00854473003019EL-anti-CCP/2104-122104-1222016-08-15
00854473003026EL-ANA Profiles: anti-dsDNA104-201104-2012016-08-15
00854473003033EL-RF/3 IgM, IgG, IgA303-305303-3052016-08-15
00854473003040EL-B2GPI IgM, IgG, IgA401-404401-4042016-08-15
00854473003057EL-ANA PROFILES: EL-ANAscr100-004100-0042016-08-15
00854473003064EL-RF IgM301-305301-3052016-08-15
00854473003071EL-ANA PROFILES: ANA/9104-005104-0052016-08-15
00854473003088EL-ANA PROFILES: ANA/7102-005102-0052016-08-15
00854473003095EL-ANA Profiles: anti-ssDNA104-101104-1012016-08-15
00854473003101EL-ANA Profiles: anti-Sm104-501104-5012016-08-15
00854473003118EL-ANA Profiles: anti-RNP/Sm104-601104-6012016-08-15
00854473003125EL-ANA Profiles: anti-SSA104-301104-3012016-08-15
00854473003149EL-ANA Profiles: anti-HISTONE104-701104-7012016-08-15
00854473003156EL-ANA Profiles: anti-Scl-70104-801104-8012016-08-15