Identity
- Trade Name
- QUANTA Lite® ACA IgG 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 IgG III Control 4. 1x 1.2mL prediluted ACA IgG III Calibrator A 5. 1x 1.2mL prediluted ACA IgG III Calibrator B 6. 1x 1.2mL prediluted ACA IgG III Calibrator C 7. 1x 1.2mL prediluted ACA IgG III Calibrator D 8. 1x 1.2mL prediluted ACA IgG III Calibrator E 9. 1x 50mL ACA III Sample Diluent 10. 1x 50mL ACA III PBS Concentrate, 20x concentrate 11. 1x 10mL HRP IgG Conjugate, (goat), anti-human IgG 12. 1x 10mL TMB Chromogen 13. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid FDA UDI
- Model / Reference
- 708625 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 IgG III Control 4. 1x 1.2mL prediluted ACA IgG III Calibrator A 5. 1x 1.2mL prediluted ACA IgG III Calibrator B 6. 1x 1.2mL prediluted ACA IgG III Calibrator C 7. 1x 1.2mL prediluted ACA IgG III Calibrator D 8. 1x 1.2mL prediluted ACA IgG III Calibrator E 9. 1x 50mL ACA III Sample Diluent 10. 1x 50mL ACA III PBS Concentrate, 20x concentrate 11. 1x 10mL HRP IgG Conjugate, (goat), anti-human IgG 12. 1x 10mL TMB Chromogen 13. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08426950472773 FDA UDI
- 510(k) Number
- K946034 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 IgG 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
- AESKULISA® Cardiolipin-Check — Aesku.Diagnostics GmbH & Co. KG · Class II
- 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
Cleared under the same submission
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 cea28b56-9a35-45a5-a59f-f451f8616e5c 36 fields · synced Jun 1, 2026