Identity
- Trade Name
- Anti-Jo-1 ELISA FDA UDI
- Generic Name
- Jo-1 antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Anti-Jo-1 ELISA is a test system for the quantitative measurement of class autoantibodies against Jo-1 in human serum or plasma. FDA UDI
- Model / Reference
- EIA-3581 FDA UDI
- Description
- Anti-Jo-1 ELISA is a test system for the quantitative measurement of class autoantibodies against Jo-1 in human serum or plasma. FDA UDI
Identifiers
- Catalog Number
- EIA-3581 FDA UDI
- Primary DI / UDI-DI
- 04048474035810 FDA UDI
- 510(k) Number
- K962053 FDA UDI
- FDA Product Code
- LJM FDA UDI
- GMDN Term
- Jo-1 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
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: Jo-1 antibody IVD, kit, enzyme immunoassay (EIA)
Anti-Jo-1 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 Jo-1 antibody IVD, kit, enzyme immunoassay (EIA).
- EL-ANA Profiles: anti-Jo-1 — THERATEST LABORATORIES, INC.
- DIASTAT anti-Jo-1 — Euro-Diagnostica AB · Class II
- Trinity Biotech — CLARK LABORATORIES, INC. · Class II
- ELISA Jo-1 Test System — ZEUS SCIENTIFIC, INC.
- Jo-1 IgG ELISA — DRG International, Inc. · Class II
- Anti-Jo-1 ELISA — DRG International, Inc. · Class II
- ELISA Jo-1 Smart Kit Test System — ZEUS SCIENTIFIC, INC.
- ReQuest — QUEST INTERNATIONAL, INC. · Class II
Cleared under the same submission
K962053 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 |
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Manufacturer
Sources (1)
- FDA UDI 36590c13-e6d5-4b10-a9fe-8d33dd0273dd 37 fields · synced Jun 8, 2026