FDA.reportPublic FDA data

Autostat II Anti-Thyroglobulin

Primary DI
00816879020038
Brand
Autostat II Anti-Thyroglobulin
Company
HYCOR BIOMEDICAL LLC
Model
FGA03
Device description
96 well ELISA for the detection of Thyroglobulin 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
DDCThyroglobulin, Antigen, Antiserum, Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DDCThyroglobulin, Antigen, Antiserum, ControlImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K943625000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K943625000AUTOSTAT II ANTI-THYROGLOBULINCogent Diagnotics , Ltd.1994-12-22DDC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816879020038PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816879020038008168790200388168790200380816879020038

GMDN Terms#

Term, Definition table
TermDefinition
Thyroglobulin 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 thyroglobulin 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

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
04048474041101Anti-Thyroglobulin (Anti-Tg) ELISADRG Instruments Gesellschaft mit beschränkter HaftungDDC2023-08-31
04048474027914TPO IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungDDC2023-08-29
00840239027894Cardiolipin IgM ELISADRG International IncDDC2023-08-24
00840239027917TPO IgG ELISADRG International IncDDC2023-08-24
00840239041104Anti-Thyroglobulin (Anti-Tg) ELISADRG International IncDDC2019-03-20
00816870020389Anti-Tg AccuBind ELISA Test System - 96 WellsMONOBIND, INC.DDC2019-02-11
00816870022062Anti-Tg AccuLite CLIA Test System - 96 WellsMONOBIND, INC.DDC2019-02-11
05056080500027NAREMEL EUROPE LIMITEDDDC2016-12-09
05056080500034NAREMEL EUROPE LIMITEDDDC2016-12-09
08426950454465QUANTA Lite® Thyroid T ELISAINOVA DIAGNOSTICS, INC.DDC2016-08-31
00850487007241ReQuest QUEST INTERNATIONAL, INC.DDC2016-08-31
00850487007494SeraQuestQUEST INTERNATIONAL, INC.DDC2016-08-31