FDA.reportPublic FDA data

QUANTA Lite® GBM ELISA

Primary DI
08426950454533
Brand
QUANTA Lite® GBM ELISA
Company
INOVA DIAGNOSTICS, INC.
Model
708740
Device description
1. 1x GBM ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted GBM ELISA Low Positive4. 1x 1.2mL prediluted GBM ELISA High Positive5. 1x 50mL HRP Sample Diluent6. 1x 25mL HRP Wash Concentrate, 40x concentrate7. 1x 10mL HS HRP IgG Conjugate, (goat), anti-human IgG8. 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
MVJDevices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MVJDevices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)Immunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K984336000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K984336000QUANTA LITE GBM ELISAInova Diagnostics, Inc.1999-02-08MVJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08426950454533PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08426950454533084269504545338426950454533

GMDN Terms#

Term, Definition table
TermDefinition
Glomerular basement membrane antibody (Goodpasture 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 antibodies to glomerular basement membrane (anti-GBM) or Goodpasture antibodies in a clinical specimen.

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
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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
00845533002028Glomerular Basement Membrane (Primate Kidney)ZEUS SCIENTIFIC, INC.MVJ2025-10-17
04049016108832EUROPLUS Granulocyte Mosaic 25 EUROPatternEUROIMMUN Medizinische Labordiagnostika AGMVJ2018-06-04
04049016108849EUROPLUS Granulocyte Mosaic 25 EUROPatternEUROIMMUN Medizinische Labordiagnostika AGMVJ2018-06-04
04049016108856EUROPLUS Granulocyte Mosaic 25 EUROPatternEUROIMMUN Medizinische Labordiagnostika AGMVJ2018-06-04
04049016108863EUROPLUS Granulocyte Mosaic 25 EUROPatternEUROIMMUN Medizinische Labordiagnostika AGMVJ2018-06-04
04049016119920EUROPLUS Granulocyte Mosaic 25 EUROPatternEUROIMMUN Medizinische Labordiagnostika AGMVJ2018-06-04
04049016135883EUROPLUS Granulocyte Mosaic 25 EUROPatternEUROIMMUN Medizinische Labordiagnostika AGMVJ2018-06-04
04049016135890EUROPLUS Granulocyte Mosaic 25 EUROPatternEUROIMMUN Medizinische Labordiagnostika AGMVJ2018-06-04
04049016135968EUROPLUS Granulocyte Mosaic 25 EUROPatternEUROIMMUN Medizinische Labordiagnostika AGMVJ2018-06-04
00816879020137Autostat II Anti-GBMHYCOR BIOMEDICAL LLCMVJ2016-09-26
07333066014630EliA GBM WellPhadia ABMVJ2016-09-23
07333066010670EliA GBM WellPhadia ABMVJ2016-09-23
05391516747943Trinity BiotechMARDX DIAGNOSTICS, INC.MVJ2016-09-19
00813545022938GBM P KDY Test(L) 48 SCIMEDX CORPORATIONMVJ2016-09-19
00813545022945GBM P KDY Test(L) 96 SCIMEDX CORPORATIONMVJ2016-09-19
05391516747585Trinity BiotechMARDX DIAGNOSTICS, INC.MVJ2016-09-18
05391516748001Trinity BiotechMARDX DIAGNOSTICS, INC.MVJ2016-09-18
05391516748018Trinity BiotechMARDX DIAGNOSTICS, INC.MVJ2016-09-18
00813545020583P KDY Pack 4 WELLSCIMEDX CORPORATIONMVJ2016-09-16
00813545020606P KDY Pack 8 WELLSCIMEDX CORPORATIONMVJ2016-09-16
00847865000536BioPlex 2200BIO-RAD LABORATORIES, INC.MVJ2016-09-12
00847865002387BioPlex 2200BIO-RAD LABORATORIES, INC.MVJ2016-09-12
00847865002394BioPlex 2200BIO-RAD LABORATORIES, INC.MVJ2016-09-12
00847865010955BioPlex 2200BIO-RAD LABORATORIES, INC.MVJ2016-09-12
00847865011082BioPlex 2200BIO-RAD LABORATORIES, INC.MVJ2016-09-12
08426950584650QUANTA Flash® GBM ReagentsINOVA DIAGNOSTICS, INC.MVJ2016-08-31
08426950595823QUANTA Lite® GBM ELISA Bulk PackINOVA DIAGNOSTICS, INC.MVJ2016-08-31