FDA.reportPublic FDA data

Autostat II Anti-Thyroid Peroxidase

Primary DI
00816879020045
Brand
Autostat II Anti-Thyroid Peroxidase
Company
HYCOR BIOMEDICAL LLC
Model
FGA04
Device description
96 well ELISA for the detection of anti-TPO antibodies in human serum
Published
2016-09-26
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JNLImmunochemical, Thyroglobulin Autoantibody

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JNLImmunochemical, Thyroglobulin AutoantibodyImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K943580000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K943580000AUTOSTAT II ANTI-TPOCogent Diagnotics , Ltd.1995-04-17JNL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816879020045PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816879020045008168790200458168790200450816879020045

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 Celsius2 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-382-2527Customerservices-us@hycorbiomedical.com

Regulatory Flags#

DUNS number
010558476
Device count
1
Kit
true
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810053950128NOVEOS Brazil Nut, Bertholletia excelsaF0188632330Z2026-05-29
00810053950203NOVEOS Coconut, Cocos nuciferaF0368634210Z2026-05-29
00810053950210NOVEOS Tuna, Thunnus sp.F0408632420Z2026-05-29
00810053950227NOVEOS Salmon, Salmo salarF0418638910Z2026-05-29
00810053950265NOVEOS Egg Yolk, Gallus gallusF07563247Z2026-05-29
00810053950340NOVEOS Pecan Nut, Carya illinoensisF2018633630Z2026-05-29
00810053950364NOVEOS Pistachio Nut, Pistacia veraF2038632630Z2026-05-29
00810053950418NOVEOS Oyster, Ostrea edulisF2908633830Z2026-05-29
00816879023794NOVEOS Brazil Nut, Bertholletia excelsaF01886323302026-05-29
00816879023824NOVEOS Tuna, Thunnus sp.F04086324202026-05-29
00816879023886NOVEOS Pistachio Nut, Pistacia veraF20386326302026-05-29
00816879024548NOVEOS Salmon, Salmo salarF04186389102026-05-29
00816879024760NOVEOS Pecan Nut, Carya illinoensisF20186336302026-05-29
00816879025057NOVEOS Oyster, Ostrea edulisF29086338302026-05-29
00816879025149NOVEOS Egg Yolk, Gallus gallusF075632472026-05-29
00816879027372NOVEOS Coconut, Cocos nuciferaF03686342102026-05-29
00816879020212Autostat II Anti-Nuclear Antibody (ANA) ScreenFGA212016-09-26
00810053950098NOVEOS Peanut, Arachis hypogaeaF01363229Z2026-01-22
00810053950272NOVEOS Bos d 4 α-lactalbumin, MilkF076C63248Z2026-01-22
00810053950289NOVEOS Bos d 5 b-lactoglobulin, MilkF077C63249-3Z2026-01-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048474041149Anti-Thyroid Peroxidase (Anti-TPO) ELISA DRG Instruments Gesellschaft mit beschränkter HaftungJNL2023-08-31
00840239041142Anti-Thyroid Peroxidase (Anti-TPO) ELISADRG International IncJNL2019-03-20
00816870020396Anti-TPO AccuBind ELISA Test System - 96 WellsMONOBIND, INC.JNL2019-02-11
00816870022079Monobind AccuLite Anti-TPO CLIA Kit - 96 WellsMONOBIND, INC.JNL2019-02-11
00613745030203ImmunoWELL TPO IgG Quantitative TestGenBioJNL2016-09-24
00613745030302ImmunoWELL Thyroglobulin IgG Quantitative TestGenBioJNL2016-09-24
00613745039121ImmunoDOT Thyroid Positive ControlGenBioJNL2016-09-24
00613745058252ImmunoDOT Thyroid Autoimmunity PanelGenBioJNL2016-09-24
00613745058894ImmunoDOT Thyroid Autoimmunity PanelGenBioJNL2016-09-24
07333066003993ImmunoCAP Specific IgG, Antigen tg, ThyroglobulinPhadia ABJNL2016-09-23
07333066004006ImmunoCAP Specific IgG, Antigen tg, ThyroglobulinPhadia ABJNL2016-09-23
05391516743808Trinity BiotechCLARK LABORATORIES, INC.JNL2016-09-22
15099590202910Access Thyroglobulin Antibody IIBeckman Coulter, Inc.JNL2016-09-09