Identity
- Trade Name
- ENA-6-Profile ELISA FDA UDI
- Generic Name
- Multiple extractable nuclear antigen (ENA) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The DRG ENA Profile-6 ELISA test system is a semi-quantitative immunoassays for the detection of IgG antibodies to Jo-1, Sm, Sm/RNP, SSA(Ro), SSB(La), and Scl-70 in human sera. When performed according to these instructions, the results of this autoantibody profile in the diagnosis and treatment of autoimmune connective tissue disorders FDA UDI
- Model / Reference
- EIA-2780 FDA UDI
- Description
- The DRG ENA Profile-6 ELISA test system is a semi-quantitative immunoassays for the detection of IgG antibodies to Jo-1, Sm, Sm/RNP, SSA(Ro), SSB(La), and Scl-70 in human sera. When performed according to these instructions, the results of this autoantibody profile in the diagnosis and treatment of autoimmune connective tissue disorders FDA UDI
Identifiers
- Catalog Number
- EIA-2780 FDA UDI
- Primary DI / UDI-DI
- 00840239027801 FDA UDI
- 510(k) Number
- K941409 FDA UDI
- FDA Product Code
- LJM FDA UDI
- GMDN Term
- Multiple extractable nuclear antigen (ENA) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5100 FDA UDI
- Commercial Distribution
- Not 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
ENA-6-Profile ELISA by DRG International, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Sm RNP 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 |
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Manufacturer
- Manufacturer
- DRG International, Inc.
Sources (1)
- FDA UDI 147920b2-4693-460f-8819-617017208f34 38 fields · synced May 30, 2026