FDA.reportPublic FDA data

QUANTA Lite® Gliadin IgA II ELISA

Primary DI
08426950448334
Brand
QUANTA Lite® Gliadin IgA II ELISA
Company
INOVA DIAGNOSTICS, INC.
Model
704525
Device description
1. 1x Gliadin IgA II ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted Gliadin IgA II ELISA Low Positive4. 1x.2mL prediluted Gliadin IgA II ELISA High Positive5. 1x 50mL HRP Sample Diluent6. 1x 25mL HRP Wash Concentrate, 40x concentrate7. 1x 10mL HRP IgA Conjugate, (goat), anti-human 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
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
08426950448334PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08426950448334084269504483348426950448334

GMDN Terms#

Term, Definition table
TermDefinition
Gliadin antibody IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of anti-gliadin antibodies in a clinical specimen.

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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00195126001045NOVA Lite® IFA Yo (PCA-1) Positive Control7040092026-06-09
08430793040761Aptiva® APS IgG Calibrators7251012024-03-11
08426950514190QUANTA Lite® C1q CIC ELISA7046202026-04-20
08430793041140Aptiva® Optical Cleaning SolutionAC10032024-03-11
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
04048474033700Gliadin IgA ELISA DRG Instruments Gesellschaft mit beschränkter HaftungMST2023-08-29
04048474033717Gliadin IgG ELISA DRG Instruments Gesellschaft mit beschränkter HaftungMST2023-08-29
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
00845714002663Immco Diagnostics, Inc.IMMCO DIAGNOSTICS, INC.MST2017-09-26
00845714002670Immco Diagnostics, Inc.IMMCO DIAGNOSTICS, INC.MST2017-09-26
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04250289504843AESKULISA® DGP-CheckAesku.Diagnostics GmbH & Co. KGMST2017-03-01
04250289502856AESKULISA® Glia-A Aesku.Diagnostics GmbH & Co. KGMST2017-02-28
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