Identity
- Trade Name
- ImmunoDOT Negative Control FDA UDI
- Generic Name
- Multiple antinuclear antibody (ANA) screening IVD, control FDA UDI
- Device Name
- Substitute Negative Control for specimen. Otherwise follow the Procedure as described in the ImmunoDOT Test package insert. FDA UDI
- Model / Reference
- 800-3920 FDA UDI
- Description
- Substitute Negative Control for specimen. Otherwise follow the Procedure as described in the ImmunoDOT Test package insert. FDA UDI
Identifiers
- Catalog Number
- 3920 FDA UDI
- Primary DI / UDI-DI
- 00613745039206 FDA UDI
- 510(k) Number
- K896347 FDA UDI
- FDA Product Code
- LJM FDA UDI
- GMDN Term
- Multiple antinuclear antibody (ANA) screening IVD, control 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
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: Multiple antinuclear antibody (ANA) screening IVD, control
ImmunoDOT Negative Control by Genbio — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K896347 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
- Genbio
Sources (1)
- FDA UDI 7d297c39-bbc4-4f28-be00-1a2ba17a4959 38 fields · synced May 30, 2026