Identity
- Trade Name
- Anti-Scl-70 ELISA (IgG) FDA UDI
- Generic Name
- Scleroderma-70 antibody (anti-Scl-70) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Model / Reference
- EA 1599-9601 G FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04049016027058 FDA UDI
- 510(k) Number
- K123261 FDA UDI
- FDA Product Code
- LLL FDA UDI
- GMDN Term
- Scleroderma-70 antibody (anti-Scl-70) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5100 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
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)
Anti-Scl-70 ELISA (IgG) by EUROIMMUN Medizinische Labordiagnostika AG — Class II — 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
- Autoimmune EIA — Bio-Rad Laboratories · Class II
- 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
- EL-ANA Profiles: anti-Scl-70 — THERATEST LABORATORIES, INC.
- Anti-Scl-70 ELISA — DRG International, Inc. · Class II
Cleared under the same submission
K123261 also covers:
- Anti-Centromeres ELISA (IgG) — EUROIMMUN Medizinische Labordiagnostika AG
- Anti-Jo-1 ELISA (IgG) — EUROIMMUN Medizinische Labordiagnostika AG
- Anti-SS-A ELISA (IgG) — EUROIMMUN Medizinische Labordiagnostika AG
- Anti-SS-B ELISA (IgG) — EUROIMMUN Medizinische Labordiagnostika AG
- Anti-Sm ELISA (IgG) — EUROIMMUN Medizinische Labordiagnostika AG
- Anti-nRNP/Sm ELISA (IgG) — EUROIMMUN Medizinische Labordiagnostika AG
- Anti-ribosomal P Proteins ELISA (IgG) — EUROIMMUN Medizinische Labordiagnostika AG
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
- EUROIMMUN Medizinische Labordiagnostika AG
Sources (1)
- FDA UDI 5dc6e60d-392d-4f26-b940-c815c7541b75 34 fields · synced May 30, 2026