FDA.reportPublic FDA data

QUANTA Lite® h-tTG /DGP Screen ELISA

Primary DI
08426950593300
Brand
QUANTA Lite® h-tTG /DGP Screen ELISA
Company
INOVA DIAGNOSTICS, INC.
Model
704575
Device description
1. 1x h-tTG/DGP Screen ELISA microwell plate (12-1 x 8 wells), with holder2.1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted h-tTG/DGP Screen ELISA Low Positive4. 1x 1.2mL prediluted h-tTG/DGP Screen ELISA High Positive5. 1x 50mL HRP Sample Diluent6. 1x 25mL HRP Wash Concentrate, 40x concentrate7. 1x 10mL HRP h-tTG/DGP IgG/IgA, (goat), anti-human IgG and IgA8. 1x 10mL TMB Chromogen9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid
Published
2016-08-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MSTAntibodies, Gliadin
MVMAutoantibodies, Endomysial(Tissue Transglutaminase)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MSTAntibodies, GliadinImmunology2
MVMAutoantibodies, Endomysial(Tissue Transglutaminase)Immunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K070083000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070083000QUANTA LITE H-TTG/DGP SCREENInova Diagnostics, Inc.2007-03-12MST

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08426950593300PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08426950593300084269505933008426950593300

GMDN Terms#

Term, Definition table
TermDefinition
Multiple Coeliac disease-associated antibody IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative screening for one or multiple antibodies associated with Coeliac disease in a clinical specimen, using an enzyme immunoassay (EIA) method. These antibodies may include autoimmune antibodies directed at gliadin (anti-gliadin IgA or IgG), endomysium (anti-endomysial antibodies), immunoglobulin A (anti-IgA) and/or tissue transglutaminase antibodies (anti-tTG).

Storage And Handling#

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

Contacts#

Phone, Email table
PhoneEmail
1-800-545-9495support@inovadx.com

Regulatory Flags#

DUNS number
188354831
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

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