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QUANTA LITE® Gliadin IgA II ELISA Bulk Pack Lab Corp

Primary DI
08426950593973
Brand
QUANTA LITE® Gliadin IgA II ELISA Bulk Pack Lab Corp
Company
INOVA DIAGNOSTICS, INC.
Model
704525.10L
Device description
1. 10x Gliadin IgA II ELISA microwell plates (12-1 x 8 wells), with holder2. 5x 1.2mL prediluted ELISA Negative Control 3. 5x 1.2mL prediluted Gliadin IgA II ELISA Low Positive 4. 5x 1.2mL prediluted Gliadin IgA II ELISA High Positive5. 10x 25mL HRP Wash Concentrate, 40x concentrate6. 10x 10mL HRP IgA Conjugate, (goat), anti-human IgA7. 10x 10mL TMB Chromogen8. 10x 10mL HRP Stop Solution, 0.344M Sulfuric Acid9. 9x 50mL HRP Sample Diluent
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MSTAntibodies, GliadinImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K052143000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K052143000QUANTA LITE GLIADIN IGA IIInova Diagnostics, Inc.2005-10-04MST

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08426950593973PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08426950593973084269505939738426950593973

GMDN Terms#

Term, Definition table
TermDefinition
Gliadin 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 anti-gliadin antibodies in a clinical specimen, using an enzyme immunoassay (EIA) method. This test is intended to be used as an aid in the diagnosis of Coeliac disease.

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
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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08426950454373QUANTA Lite® ANA ELISA7087502016-08-31
08426950456193NOVA Lite® HEp-2 ANA Kit7081002016-08-31
08426950593461NOVA Lite® HEp-2 ANA Kit7081012016-08-31
08426950593577NOVA Lite® ANA Kit with DAPI7081022016-08-31
08426950594208NOVA Lite® HEp-2 External EB Kits7042352016-08-31
08426950594857NOVA Lite® Auto AB Panel 7081802016-08-31
08426950595267NOVA Lite® HEp-2 External EB Kits7042302016-08-31
08430793040181Aptiva® CTD Essential Calibrators7231012023-12-14
08430793040198Aptiva® CTD Essential Controls7231022023-12-14
08426950506324NOVA Lite® ANA KSL Kit7083902016-08-31
08426950514008NOVA Lite® ANA KSL Kit7083802016-08-31
08426950514176NOVA Lite®Rat Liver , Kidney, Stomach Kit7041702016-08-31
08426950545798NOVA Lite®Rat Liver , Kidney, Stomach Kit7041802016-08-31
08426950593539NOVA Lite® HEp-2 ANA Plus Mouse Kidney & Stomach7081502016-08-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00840239033703Gliadin IgA ELISA DRG International IncMST2023-08-24
00840239033710Gliadin IgG ELISA DRG International IncMST2023-08-24
08430793040471Aptiva® Celiac Disease IgG ReagentINOVA DIAGNOSTICS, INC.MST2022-05-27
08430793040532Aptiva® Celiac Disease IgA ReagentINOVA DIAGNOSTICS, INC.MST2022-05-27
00894175000428AccuDiag ™Diagnostic Automation, Inc.MST2021-08-06
00847865013000BioPlex 2200BIO-RAD LABORATORIES, INC.MST2020-01-30
07333066019901ImmunoCAP Gliadin IgA/IgG Control LowPhadia ABMST2019-03-29
07333066019918ImmunoCAP Gliadin IgA Control HighPhadia ABMST2019-03-29
07333066019925ImmunoCAP Gliadin IgG Control HighPhadia ABMST2019-03-29
07333066000701ImmunoCAP Gliadin IgA/IgG Control LowPhadia ABMST2019-03-29
07333066000718ImmunoCAP Gliadin IgA Control HighPhadia ABMST2019-03-29
07333066000725ImmunoCAP Gliadin IgG Control HighPhadia ABMST2019-03-29
07333066019819ImmunoCAP Specific IgA/IgG Sample DiluentPhadia ABMST2019-03-28
07333066000732ImmunoCAP Specific IgA/IgG Sample DiluentPhadia ABMST2019-03-28
07333066019550ImmunoCAP Specific IgA CalibratorsPhadia ABMST2019-03-26
07333066019574ImmunoCAP Specific IgA Curve ControlsPhadia ABMST2019-03-26
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