Identity
- Trade Name
- EL-ANA Profiles: anti-Scl-70 FDA UDI
- Generic Name
- Scleroderma-70 antibody (anti-Scl-70) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- ANTI-SCL-70 ANTIBODY ELISA TEST KIT, 96 TESTS FDA UDI
- Model / Reference
- 104-801 FDA UDI
- Description
- ANTI-SCL-70 ANTIBODY ELISA TEST KIT, 96 TESTS FDA UDI
Identifiers
- Catalog Number
- 104-801 FDA UDI
- Primary DI / UDI-DI
- 00854473003156 FDA UDI
- 510(k) Number
- K051066 FDA UDI
- GMDN Term
- Scleroderma-70 antibody (anti-Scl-70) 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: Scleroderma-70 antibody (anti-Scl-70) IVD, kit, enzyme immunoassay (EIA)
EL-ANA Profiles: anti-Scl-70 by Theratest Laboratories, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Scleroderma-70 antibody (anti-Scl-70) IVD, kit, enzyme immunoassay (EIA).
- QUANTA Lite® Scl-70 ELISA — INOVA DIAGNOSTICS, INC. · Class II
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- Trinity Biotech — CLARK LABORATORIES, INC. · Class II
- ReQuest — QUEST INTERNATIONAL, INC. · Class II
- Anti-Scl-70 ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung · Class II
- Gold Standard Diagnostics Is-anti-Scl-70 ELISA Test Kit — Gold Standard Diagnostics, LLC · Class II
- Anti-Scl-70 ELISA — DRG International, Inc. · Class II
- Sci-70 IgG ELISA — DRG International, Inc. · Class II
Cleared under the same submission
K051066 also covers:
- EL-ANA PROFILES: ANA/4 — THERATEST LABORATORIES, INC.
- EL-ANA PROFILES: ANA/4 — THERATEST LABORATORIES, INC.
- EL-ANA PROFILES: ANA/6 — THERATEST LABORATORIES, INC.
- EL-ANA PROFILES: ANA/7 — THERATEST LABORATORIES, INC.
- EL-ANA PROFILES: ANA/8 — THERATEST LABORATORIES, INC.
- EL-ANA PROFILES: ANA/9 — THERATEST LABORATORIES, INC.
- EL-ANA Profiles: anti-HISTONE — THERATEST LABORATORIES, INC.
- EL-ANA Profiles: anti-RNP/Sm — THERATEST LABORATORIES, INC.
- EL-ANA Profiles: anti-SSA — THERATEST LABORATORIES, INC.
- EL-ANA Profiles: anti-Sm — THERATEST LABORATORIES, INC.
- EL-ANA Profiles: anti-dsDNA — THERATEST LABORATORIES, INC.
- EL-ANA Profiles: anti-ssDNA — THERATEST LABORATORIES, INC.
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 8d7088f4-34b8-4789-ab8b-b277bf1e610b 36 fields · synced May 30, 2026