Identity
- Trade Name
- QUANTA Lite® ACA Screen III FDA UDI
- Generic Name
- Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- 1. 1x Cardiolipin ELISA microwell plate (12-1 x 8 wells), with holder 2. 1x 1.2mL prediluted ACA Negative Control 3. 1x 1.2mL prediluted ACA III Decision Point 4. 1x 1.2mL prediluted ACA III Screen Control 5. 1x 50mL ACA III Sample Diluent 6. 1x 50mL ACA III PBS Concentrate, 20x concentrate 7. 1x 10mL HRP IgGAM Conjugate, (goat), anti-human IgGAM 8. 1x 10mL TMB Chromogen 9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid FDA UDI
- Model / Reference
- 708620 FDA UDI
- Description
- 1. 1x Cardiolipin ELISA microwell plate (12-1 x 8 wells), with holder 2. 1x 1.2mL prediluted ACA Negative Control 3. 1x 1.2mL prediluted ACA III Decision Point 4. 1x 1.2mL prediluted ACA III Screen Control 5. 1x 50mL ACA III Sample Diluent 6. 1x 50mL ACA III PBS Concentrate, 20x concentrate 7. 1x 10mL HRP IgGAM Conjugate, (goat), anti-human IgGAM 8. 1x 10mL TMB Chromogen 9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08426950454489 FDA UDI
- 510(k) Number
- K953291 FDA UDI
- FDA Product Code
- MID FDA UDI
- GMDN Term
- Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5660 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA)
QUANTA Lite® ACA Screen III by Inova Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA).
- REAADS IgA Anti-Cardiolipin Semi-Quantitative Test Kit (96-Well) — CORGENIX MEDICAL CORPORATION · Class II
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- RELISA® Cardiolipin IgG & IgM Antibody Test — IMMUNO CONCEPTS INC
- Anti-Cardiolipin IgA ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung · Class II
- Autoimmune EIA — Bio-Rad Laboratories · Class II
- Cardiolipin IgM ELISA — DRG International, Inc. · Class II
- REAADS Anti-Cardiolipin IgG/IgM Semi-Quantitative Test Kit (96 Well) — CORGENIX MEDICAL CORPORATION · Class II
- Cardiolipin IgA ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Inova Diagnostics, Inc.
Sources (1)
- FDA UDI 31ed8cb1-20f6-412b-9878-a903187664fc 36 fields · synced May 29, 2026