Identity
- Trade Name
- DIASTAT anti-dsDNA FDA UDI
- Generic Name
- Double stranded DNA antibody (anti-dsDNA) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Model / Reference
- FDNA100 FDA UDI
Identifiers
- Catalog Number
- FDNA100 FDA UDI
- Primary DI / UDI-DI
- 07340058410035 FDA UDI
- 510(k) Number
- K905386 FDA UDI
- FDA Product Code
- KTL FDA UDI
- GMDN Term
- Double stranded DNA antibody (anti-dsDNA) 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
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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: Double stranded DNA antibody (anti-dsDNA) IVD, kit, enzyme immunoassay (EIA)
DIASTAT anti-dsDNA by Euro-Diagnostica AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Double stranded DNA antibody (anti-dsDNA) IVD, kit, enzyme immunoassay (EIA).
- Anti-dsDNA IgG ELISA — DRG International, Inc. · Class II
- ELISA dsDNA Test System — ZEUS SCIENTIFIC, INC.
- IMMCO DIAGNOSTICS — Immco Diagnostics, Inc. · Class II
- EL-ANA PROFILES: ANA/4 — THERATEST LABORATORIES, INC.
- EL-ANA PROFILES: ANA/4 — THERATEST LABORATORIES, INC.
- QUANTA Lite® dsDNA SC ELISA — INOVA DIAGNOSTICS, INC. · Class II
- QUANTA Lite® HA dsDNA ELISA — INOVA DIAGNOSTICS, INC. · Class II
- EL-ANA Profiles: anti-dsDNA — THERATEST LABORATORIES, INC.
Cleared under the same submission
K905386 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
- Manufacturer
- Euro-Diagnostica AB
Sources (1)
- FDA UDI 0e1e6c3a-dc8d-4f65-82b1-8c2182f550f1 34 fields · synced May 30, 2026