Identity
- Trade Name
- DNA(C. luciliae) 100 Test(L) FDA UDI
- Generic Name
- Native DNA antibody (anti-nDNA) IVD, kit, fluorescent immunoassay FDA UDI
- Model / Reference
- 6100L FDA UDI
Identifiers
- Catalog Number
- 6100L FDA UDI
- Primary DI / UDI-DI
- 00813545023119 FDA UDI
- FDA Product Code
- KTL FDA UDI
- GMDN Term
- Native DNA antibody (anti-nDNA) IVD, kit, fluorescent immunoassay 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Native DNA antibody (anti-nDNA) IVD, kit, fluorescent immunoassay
DNA(C. luciliae) 100 Test(L) by Scimedx Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Native DNA antibody (anti-nDNA) IVD, kit, fluorescent immunoassay.
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- IgG Anti-nDNA Fluorescent Test System — IMMUNO CONCEPTS INC
- IMMCO DIAGNOSTICS — Immco Diagnostics, Inc. · Class II
- Fluorescent nDNA Test System — IMMUNO CONCEPTS INC
- IgG Anti-nDNA Fluorescent Test System — IMMUNO CONCEPTS INC
- IgG Anti-nDNA Fluorescent Test System — IMMUNO CONCEPTS 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
- Scimedx Corp.
Sources (1)
- FDA UDI 5491a12b-f5ad-4a53-954e-03234d26f164 34 fields · synced May 30, 2026