FDA.reportPublic FDA data

QUANTA LITE® ACA IgM III ELISA Bulk Pack Kit (Lab Corp)

Primary DI
08426950594062
Brand
QUANTA LITE® ACA IgM III ELISA Bulk Pack Kit (Lab Corp)
Company
INOVA DIAGNOSTICS, INC.
Model
708630.10L
Device description
1. 10x ACA IgM III ELISA microwell plates (12-1 x 8 wells), with holder2. 5x 1.2mL prediluted ACA Negative Control 3. 5x 1.2mL prediluted ACA IgM III Control4. 5x 1.2mL prediluted ACA IgM III Calibrator A5. 5x 1.2mL prediluted ACA IgM III Calibrator B6. 5x 1.2mL prediluted ACA IgM III Calibrator C7. 5x 1.2mL prediluted ACA IgM III Calibrator D8. 5x 1.2mL prediluted ACA IgM III Calibrator E9. 9x 50mL ACA III Sample Diluent10. 10x 50mL ACA III PBS Concentrate, 20x concentrate11. 10x 10mL HRP ACA IgM Conjugate, (goat), anti-human IgM12. 10x 10mL TMB Chromogen13. 10x 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
MIDSystem, Test, Anticardiolipin Immunological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MIDSystem, Test, Anticardiolipin ImmunologicalImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K946385000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K946385000QUANTA LITE ACA IGM (HRP)Inova Diagnostics, Inc.1995-07-18MID

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08426950594062PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08426950594062084269505940628426950594062

GMDN Terms#

Term, Definition table
TermDefinition
Anticardiolipin 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 one or multiple classes of antibodies to cardiolipin 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
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08426950456193NOVA Lite® HEp-2 ANA Kit7081002016-08-31
08426950593461NOVA Lite® HEp-2 ANA Kit7081012016-08-31
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08426950594857NOVA Lite® Auto AB Panel 7081802016-08-31
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08430793040181Aptiva® CTD Essential Calibrators7231012023-12-14
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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
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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00840239035882Anti-Cardiolipin IgA ELISADRG International IncMID2023-08-25
00840239035899Anti-Cardiolipin Screen ELISADRG International IncMID2023-08-25
00840239027887Cardiolipin IgG ELISADRG International IncMID2023-08-24
00840239027900Cardiolipin IgA ELISADRG International IncMID2023-08-24
07333066014197EliA APS Positive Control 2500/5000Phadia ABMID2020-12-09
08426951289240QUANTA Flash® aCL IgM ReagentsINOVA DIAGNOSTICS, INC.MID2019-09-27
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08426951289295QUANTA Flash® aCL IgG ReagentsINOVA DIAGNOSTICS, INC.MID2019-09-27
04048474035872Anti-Cardiolipin IgG/IgM ELISADRG Instruments Gesellschaft mit beschränkter HaftungMID2019-06-10
04048474035896Anti-Cardiolipin Screen ELISADRG Instruments Gesellschaft mit beschränkter HaftungMID2019-06-10
00404847435870Anti-Cardiolipin IgG/IgM ELISADRG Instruments Gesellschaft mit beschränkter HaftungMID2019-06-10
00404847435894Anti-Cardiolipin Screen ELISADRG Instruments Gesellschaft mit beschränkter HaftungMID2019-06-10
B24235CAAHUE010Anti-Cardiolipin-A ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.MID2017-08-28
04250289503044AESKULISA® Cardiolipin-Check Aesku.Diagnostics GmbH & Co. KGMID2017-02-28
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04250289500821AESKULISA® Cardiolipin-Check Aesku.Diagnostics GmbH & Co. KGMID2016-09-27
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