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
00810053950074NOVEOS Sesame Seed, Sesamum indicumF0108632270Z2026-07-29
00810053950104NOVEOS Soybean, Glycine maxF01463230Z2026-07-29
00810053950111NOVEOS Hazelnut, Corylus avellanaF01763232Z2026-07-29
00810053950135NOVEOS Almond, Amygdalus communisF0208634040Z2026-07-29
00810053950296NOVEOS Bos d 8 Casein, MilkF078C63250-3Z2026-07-29
00810053950319NOVEOS Lobster, Homarus gammarusF0808632520Z2026-07-29
00810053950449NOVEOS Ara h 8 PR-10, PeanutF352C63343Z2026-07-29
00810053950456NOVEOS Ara h 1, PeanutF422C63273Z2026-07-29
00810053950463NOVEOS Ara h 2, PeanutF423C63274-3Z2026-07-29
00810053950494NOVEOS Ara h 6, PeanutF447C63399Z2026-07-29
00816879023770NOVEOS Sesame Seed, Sesamum indicumF01086322702026-07-29
00816879024203NOVEOS Lobster, Homarus gammarusF08086325202026-07-29
00816879024333NOVEOS Ara h 1, PeanutF422C632732026-07-29
00816879024470NOVEOS Bos d 8 Casein, MilkF078C63250-32026-07-29
00816879024982NOVEOS Ara h 2, PeanutF423C63274-32026-07-29
00816879025323NOVEOS Ara h 8 PR-10, PeanutF352C633432026-07-29
00816879025354NOVEOS Soybean, Glycine maxF014632302026-07-29
00816879025378NOVEOS Ara h 6, PeanutF447C633992026-07-29
00816879027341NOVEOS Hazelnut, Corylus avellanaF017632322026-07-29
00816879027969NOVEOS Almond, Amygdalus communisF02086340402026-07-29

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