Identity
- Trade Name
- Sm RNP IgG ELISA FDA UDI
- Generic Name
- Ribonucleoprotein antibody (anti-RNP) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The Sm/RNP ELISA Test System is a semi-quantitative immunoassay for the detection of IgG antibodies to Sm/RNP in human sera. When performed according to these instructions, the results of this assay may aid in the diagnosis and treatment of autoimmune connective tissue disorders FDA UDI
- Model / Reference
- EIA-2785 FDA UDI
- Description
- The Sm/RNP ELISA Test System is a semi-quantitative immunoassay for the detection of IgG antibodies to Sm/RNP in human sera. When performed according to these instructions, the results of this assay may aid in the diagnosis and treatment of autoimmune connective tissue disorders FDA UDI
Identifiers
- Catalog Number
- EIA-2785 FDA UDI
- Primary DI / UDI-DI
- 04048474027853 FDA UDI
- 510(k) Number
- K941409 FDA UDI
- FDA Product Code
- LJM FDA UDI
- GMDN Term
- Ribonucleoprotein antibody (anti-RNP) 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
Yes
FDA UDI
Category: Ribonucleoprotein antibody (anti-RNP) IVD, kit, enzyme immunoassay (EIA)
Sm RNP IgG ELISA by DRG Instruments Gesellschaft mit beschränkter Haftung — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ribonucleoprotein antibody (anti-RNP) IVD, kit, enzyme immunoassay (EIA).
- AESKULISA® snRNP-C — Aesku.Diagnostics GmbH & Co. KG · Class II
- Sm RNP IgG ELISA — DRG International, Inc. · Class II
- Anti-RNP/Sm ELISA — DRG International, Inc. · Class II
- Anti-RNP/Sm ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung · Class II
Cleared under the same submission
K941409 also covers:
- Jo-1 IgG ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung
- SSA (Ro) ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung
- SSB (La) IgG ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung
- Scl-70 IgG ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung
- Sm IgG ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung
- Jo-1 IgG ELISA — DRG International, Inc.
- SSA (Ro) ELISA — DRG International, Inc.
- SSB (La) IgG ELISA — DRG International, Inc.
- Sci-70 IgG ELISA — DRG International, Inc.
- Sm IgG ELISA — DRG International, Inc.
- Sm RNP IgG ELISA — DRG International, 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 | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
Sources (1)
- FDA UDI 13f4e323-89ed-4e98-8d22-4ff0b4c63d85 37 fields · synced Jun 8, 2026