FDA.reportPublic FDA data

QUANTA Flash® h-tTG IgA Reagents

Primary DI
08426950601890
Brand
QUANTA Flash® h-tTG IgA Reagents
Company
INOVA DIAGNOSTICS, INC.
Model
701100
Device description
1. 1 QUANTA Flash h-tTG IgA reagent cartridge2. 1 Resuspension buffer 3. 1 Transfer pipet
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
K094060000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K094060000QUANTA FLASH H-TTG IGAInova Diagnostics, Inc.2010-10-13MVM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08426950601890PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08426950601890084269506018908426950601890

GMDN Terms#

Term, Definition table
TermDefinition
Tissue transglutaminase antibody IVD, kit, chemiluminescent immunoassayA 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 a chemiluminescent immunoassay 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04049016161608IFA: Oesophagus (Monkey) IgAEUROIMMUN Medizinische Labordiagnostika AGMVM2025-10-21
04049016161615IFA: Oesophagus (Monkey) IgA EUROPatternEUROIMMUN Medizinische Labordiagnostika AGMVM2025-10-21
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
00813545027094MeDiCaSCIMEDX CORPORATIONMVM2020-12-01
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
04049016119968IFA: Oesophagus (Monkey) IgA EUROPatternEUROIMMUN Medizinische Labordiagnostika AGMVM2018-01-24
04049016119975IFA: Oesophagus (Monkey) IgA EUROPatternEUROIMMUN Medizinische Labordiagnostika AGMVM2018-01-24
04049016119982IFA: Oesophagus (Monkey) IgA EUROPatternEUROIMMUN Medizinische Labordiagnostika AGMVM2018-01-24
04049016119999IFA: Oesophagus (Monkey) IgA EUROPatternEUROIMMUN Medizinische Labordiagnostika AGMVM2018-01-24
B24235TGAHUE010Anti Tissue Transglutaminase-A (Anti-tTg-A) ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.MVM2017-05-23
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