FDA.reportPublic FDA data

QUANTA Lite® aPS/PT IgM ELISA

Primary DI
08426950594796
Brand
QUANTA Lite® aPS/PT IgM ELISA
Company
INOVA DIAGNOSTICS, INC.
Model
708845
Device description
(anti-phosphatidylserine and prothrombin)1. 1 aPS/PT IgM ELISA microwell plate (12-1 x 8 wells), with holder2. 1 1.2mL prediluted ELISA Negative Control 3. 1 1.2mL prediluted aPS/PT IgM ELISA Control4. 1 1.2mL prediluted aPS/PT IgM ELISA Calibrator A5. 1 1.2mL prediluted aPS/PT IgM ELISA Calibrator B6. 1 1.2mL prediluted aPS/PT IgM ELISA Calibrator C7. 1 1.2mL prediluted aPS/PT IgM ELISA Calibrator D8. 1 1.2mL prediluted aPS/PT IgM ELISA Calibrator E9. 1 10mL HRP aPS/PT IgM Conjugate, (goat), anti-human IgM 10. 1 50mL HRP Sample Diluent Plus11. 1 25mL HRP Wash Buffer Plus, 40x concentrate12. 1 10mL TMB Chromogen13. 1 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
OPNAuto-Antibodies; Phosphatidylserine, Prothrombin, Phosphatidylserine/Prothrombin Complex

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OPNAuto-Antibodies; Phosphatidylserine, Prothrombin, Phosphatidylserine/Prothrombin ComplexImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K090755000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090755000QUANTA LITE APS/PT IGG AND IGM ELISAInova Diagnostics, Inc.2010-02-01OPN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08426950594796PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08426950594796084269505947968426950594796

GMDN Terms#

Term, Definition table
TermDefinition
Phosphatidylserine/prothrombin complex 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 phosphatidylserine/prothrombin complex (PS/PT) 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
00195126001021NOVA Lite® IFA Hu (ANNA-1) Positive Control7040732026-06-09
00195126001038NOVA Lite® IFA Pancreatic Islet Cell Positive Control7040052026-06-09
00195126001045NOVA Lite® IFA Yo (PCA-1) Positive Control7040092026-06-09
08430793040761Aptiva® APS IgG Calibrators7251012024-03-11
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08426950594864QUANTA Lite® aPS/PT IgG ELISAINOVA DIAGNOSTICS, INC.OPN2016-08-31