Identity
- Trade Name
- EL-aCL screen FDA UDI
- Generic Name
- Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- ANTI-CARDIOLIPIN ANTIBODY SCREENING ELISA TEST KIT, 192 TESTS FDA UDI
- Model / Reference
- 202-202 FDA UDI
- Description
- ANTI-CARDIOLIPIN ANTIBODY SCREENING ELISA TEST KIT, 192 TESTS FDA UDI
Identifiers
- Catalog Number
- 202-202 FDA UDI
- Primary DI / UDI-DI
- 00854473003200 FDA UDI
- 510(k) Number
- K060176 FDA UDI
- GMDN Term
- Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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)
EL-aCL screen by Theratest Laboratories, Inc. — 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
- QUANTA Lite® ACA IgG III ELISA Bulk Pack — INOVA DIAGNOSTICS, INC. · 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
- QUANTA Lite® ACA IgA III — INOVA DIAGNOSTICS, INC. · Class II
- Cardiolipin IgM ELISA — DRG International, Inc. · Class II
Cleared under the same submission
K060176 also covers:
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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Theratest Laboratories, Inc.
Sources (1)
- FDA UDI 0730fd78-cb64-469c-ac74-9800de90ac06 36 fields · synced May 29, 2026