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Gold Standard Diagnostics Is-anti-Sm/RNP ELISA Test Kit
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Gold Standard Diagnostics Is-anti-Sm/RNP ELISA Test Kit FDA UDI
- Generic Name
- Sm/RNP antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Gold Standard Diagnostics Is-anti-Sm/RNP ELISA Test Kit FDA UDI
- Model / Reference
- 720-270 FDA UDI
- Description
- Gold Standard Diagnostics Is-anti-Sm/RNP ELISA Test Kit FDA UDI
Identifiers
- Catalog Number
- 720-270 FDA UDI
- Primary DI / UDI-DI
- B3507202700 FDA UDI
- 510(k) Number
- K970238 FDA UDI
- FDA Product Code
- LLL FDA UDI
- GMDN Term
- Sm/RNP antibody 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
No
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: Sm/RNP antibody IVD, kit, enzyme immunoassay (EIA)
Gold Standard Diagnostics Is-anti-Sm/RNP ELISA Test Kit by Gold Standard Diagnostics, LLC — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Sm/RNP antibody IVD, kit, enzyme immunoassay (EIA).
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- Trinity Biotech — CLARK LABORATORIES, INC. · Class II
- ELISA Sm/RNP Smart Kit Test System — ZEUS SCIENTIFIC, INC.
- AESKULISA® Sm — Aesku.Diagnostics GmbH & Co. KG · Class II
- SeraQuest — QUEST INTERNATIONAL, INC. · Class II
Cleared under the same submission
K970238 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 | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Gold Standard Diagnostics, LLC
Sources (1)
- FDA UDI ddd80057-b26f-4864-a537-f58e77075351 36 fields · synced Jun 8, 2026