QUANTA Lite

EUDAMEDFDA UDI

Class IVD General (EU MDR)

Ref 708845

by Inova Diagnostics. Inc.

Identity

Trade Name: QUANTA Lite EUDAMED
QUANTA Lite® aPS/PT IgM ELISA FDA UDI
Generic Name: Phosphatidylserine/prothrombin complex antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name: QUANTA Lite® aPS PT IgM ELISA EUDAMED
(anti-phosphatidylserine and prothrombin) 1. 1 aPS/PT IgM ELISA microwell plate (12-1 x 8 wells), with holder 2. 1 1.2mL prediluted ELISA Negative Control 3. 1 1.2mL prediluted aPS/PT IgM ELISA Control 4. 1 1.2mL prediluted aPS/PT IgM ELISA Calibrator A 5. 1 1.2mL prediluted aPS/PT IgM ELISA Calibrator B 6. 1 1.2mL prediluted aPS/PT IgM ELISA Calibrator C 7. 1 1.2mL prediluted aPS/PT IgM ELISA Calibrator D 8. 1 1.2mL prediluted aPS/PT IgM ELISA Calibrator E 9. 1 10mL HRP aPS/PT IgM Conjugate, (goat), anti-human IgM 10. 1 50mL HRP Sample Diluent Plus 11. 1 25mL HRP Wash Buffer Plus, 40x concentrate 12. 1 10mL TMB Chromogen 13. 1 10mL HRP Stop Solution, 0.344M Sulfuric Acid FDA UDI
Model / Reference: 708845 EUDAMEDFDA UDI
Description: (anti-phosphatidylserine and prothrombin) 1. 1 aPS/PT IgM ELISA microwell plate (12-1 x 8 wells), with holder 2. 1 1.2mL prediluted ELISA Negative Control 3. 1 1.2mL prediluted aPS/PT IgM ELISA Control 4. 1 1.2mL prediluted aPS/PT IgM ELISA Calibrator A 5. 1 1.2mL prediluted aPS/PT IgM ELISA Calibrator B 6. 1 1.2mL prediluted aPS/PT IgM ELISA Calibrator C 7. 1 1.2mL prediluted aPS/PT IgM ELISA Calibrator D 8. 1 1.2mL prediluted aPS/PT IgM ELISA Calibrator E 9. 1 10mL HRP aPS/PT IgM Conjugate, (goat), anti-human IgM 10. 1 50mL HRP Sample Diluent Plus 11. 1 25mL HRP Wash Buffer Plus, 40x concentrate 12. 1 10mL TMB Chromogen 13. 1 10mL HRP Stop Solution, 0.344M Sulfuric Acid FDA UDI

Identifiers

Primary DI / UDI-DI: 08426950594796 EUDAMEDFDA UDI
Basic UDI-DI: B-08426950594796 EUDAMED
510(k) Number: K090755 FDA UDI
FDA Product Code: OPN FDA UDI
EMDN Code: W0102100502 ANTI-PHOSPHATIDYLSERIN ANTIBODIES EUDAMED
GMDN Term: Phosphatidylserine/prothrombin complex antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class: Class IVD General EUDAMED
Class II FDA UDI
Regulation Number: 866.5660 FDA UDI
Market of Registration: Italy EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Human Tissues

Yes

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

EUDAMED

Near-Patient Testing

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

EUDAMED

Surgical Instrument

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

QUANTA Lite by Inova Diagnostics, Inc. — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/IVDD

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/IVDD	B-08426950594796	Class IVD General	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class IVD General	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Inova Diagnostics. Inc.
EUDAMED SRN: US-MF-000017851
Authorised Representative: Medical Technology Promedt Consulting GmbH DE-AR-000000085

Sources (2)

EUDAMED 25f4fc75-33c8-403f-90a4-abf1c3af50e1 61 fields · synced May 31, 2026
FDA UDI 4b342d70-96bf-45b6-a11f-0c8d56de87d5 36 fields · synced May 30, 2026