FDA.reportPublic FDA data

Autostat II Anti-Tissue Transglutaminase IgG

Primary DI
00816879020267
Brand
Autostat II Anti-Tissue Transglutaminase IgG
Company
HYCOR BIOMEDICAL LLC
Model
FGA26
Device description
96 well ELISA for the detection of Anti-Tissue Transglutaminase IgG 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
MVMAutoantibodies, Endomysial(Tissue Transglutaminase)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MVMAutoantibodies, Endomysial(Tissue Transglutaminase)Immunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K043433000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K043433000AUTOSTAT II ANTI-TISSUE TRANSGLUTAMINASE IGG ELISAHycor Biomedical , Ltd.2005-03-07MVM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816879020267PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816879020267008168790202678168790202670816879020267

GMDN Terms#

Term, Definition table
TermDefinition
Tissue transglutaminase 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 tissue transglutaminase (anti-tTG) 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

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