FDA.reportPublic FDA data

QUANTA Lite® tTG ELISA

Primary DI
08426950594277
Brand
QUANTA Lite® tTG ELISA
Company
INOVA DIAGNOSTICS, INC.
Model
708730
Device description
1. 1x tTG ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. x1 1.2mL prediluted tTG ELISA Low Positive4. 1x 1.2mL prediluted tTG 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
Rx
true
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
K982366000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K982366000QUANTA LITE TTG (TISSUE TRANSGLUTAMINASE) ELISAInova Diagnostics, Inc.1998-08-27MVM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08426950594277PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08426950594277084269505942778426950594277

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

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
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
08426950596387NOVA Lite® HEp-2 ANA Plus Mouse Kidney & Stomach7081552016-08-31
08426950621843NOVA Lite® DAPI ANA Kit7043202016-08-31
08426950627692QUANTA Flash PR3 Reagents7011352024-12-13
08430793040716Aptiva® APS IgG Reagent7251002024-03-11

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Primary DI, Brand, Company table
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04049016161622IFA: Oesophagus (Monkey) IgA EUROPatternEUROIMMUN Medizinische Labordiagnostika AGMVM2025-10-21
00845533002011Endomysium (Primate esophagus)ZEUS SCIENTIFIC, INC.MVM2025-10-17
04049016144595IFA: Oesophagus (Monkey) IgA EUROPatternEUROIMMUN Medizinische Labordiagnostika AGMVM2024-05-17
08430793040471Aptiva® Celiac Disease IgG ReagentINOVA DIAGNOSTICS, INC.MVM2022-05-27
08430793040532Aptiva® Celiac Disease IgA ReagentINOVA DIAGNOSTICS, INC.MVM2022-05-27
07333066014180EliA Celiac Positive Control 2500/5000Phadia ABMVM2020-12-09
00813545026707MeDiCaSCIMEDX CORPORATIONMVM2020-12-01
00813545026714MeDiCaSCIMEDX CORPORATIONMVM2020-12-01
00813545027070MeDiCaSCIMEDX CORPORATIONMVM2020-12-01
00813545027087MeDiCaSCIMEDX CORPORATIONMVM2020-12-01
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00813545027100MeDiCaSCIMEDX CORPORATIONMVM2020-12-01
00813545027117MeDiCaSCIMEDX CORPORATIONMVM2020-12-01
00813545027216MeDiCaSCIMEDX CORPORATIONMVM2020-12-01
00847865013000BioPlex 2200BIO-RAD LABORATORIES, INC.MVM2020-01-30
07333066020075EliA IgA CalibratorsPhadia ABMVM2019-03-26
04049016027287Anti-tissue Transglutaminase ELISA (IgA)EUROIMMUN Medizinische Labordiagnostika AGMVM2019-03-06
04049016027294Anti-tissue Transglutaminase ELISA (IgG)EUROIMMUN Medizinische Labordiagnostika AGMVM2019-03-06
04049016119951IFA: Oesophagus (Monkey) IgA EUROPatternEUROIMMUN Medizinische Labordiagnostika AGMVM2018-01-24
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04049016119999IFA: Oesophagus (Monkey) IgA EUROPatternEUROIMMUN Medizinische Labordiagnostika AGMVM2018-01-24
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