FDA.reportPublic FDA data

QUANTA Lite® GBM ELISA Bulk Pack

Primary DI
08426950595823
Brand
QUANTA Lite® GBM ELISA Bulk Pack
Company
INOVA DIAGNOSTICS, INC.
Model
708740.10
Device description
1. 10x GBM ELISA microwell plates (12-1 x 8 wells), with holder2. 5x 1.2mL prediluted ELISA Negative Control 3. 5x 1.2mL prediluted GBM ELISA Low Positive4. 5x 1.2mL prediluted GBM ELISA High Positive5. 9x 50mL HRP Sample Diluent6. 10x 25mL HRP Wash Concentrate, 40x concentrate7. 10x 10mL HS HRP IgG Conjugate, (goat), anti-human IgG8. 10x 10mL TMB Chromogen9. 10x 10mL HRP Stop Solution, 0.344M Sulfuric Acid Additional Materials Required But Not Provided
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
08426950595823PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08426950595823084269505958238426950595823

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
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08426950456193NOVA Lite® HEp-2 ANA Kit7081002016-08-31
08426950593461NOVA Lite® HEp-2 ANA Kit7081012016-08-31
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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
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08426950514176NOVA Lite®Rat Liver , Kidney, Stomach Kit7041702016-08-31
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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
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08430793040716Aptiva® APS IgG Reagent7251002024-03-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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04049016135968EUROPLUS Granulocyte Mosaic 25 EUROPatternEUROIMMUN Medizinische Labordiagnostika AGMVJ2018-06-04
00816879020137Autostat II Anti-GBMHYCOR BIOMEDICAL LLCMVJ2016-09-26
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