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Gold Standard Diagnostics Is-anti-Scl-70 ELISA Test Kit
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Gold Standard Diagnostics Is-anti-Scl-70 ELISA Test Kit FDA UDI
- Generic Name
- Scleroderma-70 antibody (anti-Scl-70) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- ImmunoSimplicity (Is) Anti-Scl-70 ELISA Test Kit for the detection of antibodies against Scl-70 in human serum as an aid in the diagnosis of autoimmune disease. FDA UDI
- Model / Reference
- 720-280 FDA UDI
- Description
- ImmunoSimplicity (Is) Anti-Scl-70 ELISA Test Kit for the detection of antibodies against Scl-70 in human serum as an aid in the diagnosis of autoimmune disease. FDA UDI
Identifiers
- Catalog Number
- 720-280 FDA UDI
- Primary DI / UDI-DI
- B3507202800 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
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: Scleroderma-70 antibody (anti-Scl-70) IVD, kit, enzyme immunoassay (EIA)
Gold Standard Diagnostics Is-anti-Scl-70 ELISA Test Kit by Gold Standard Diagnostics, LLC — Class II — FDA UDI — listed in FDA GUDID
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
- EL-ANA Profiles: anti-Scl-70 — THERATEST LABORATORIES, INC.
- Anti-Scl-70 ELISA — DRG International, Inc. · Class II
- Sci-70 IgG ELISA — DRG International, Inc. · 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
- Gold Standard Diagnostics, LLC
Sources (1)
- FDA UDI 57c39795-8041-479a-8253-d142b5bb5dbf 35 fields · synced Jun 8, 2026