Identity
- Trade Name
- IMMCO DIAGNOSTICS FDA UDI
- Generic Name
- Multiple antinuclear antibody (ANA) screening IVD, reagent FDA UDI
- Device Name
- ANA Pattern Control Panel II FDA UDI
- Model / Reference
- 1602 FDA UDI
- Description
- ANA Pattern Control Panel II FDA UDI
Identifiers
- Catalog Number
- 1602 FDA UDI
- Primary DI / UDI-DI
- 00845714002168 FDA UDI
- FDA Product Code
- LKJ FDA UDI
- GMDN Term
- Multiple antinuclear antibody (ANA) screening IVD, reagent 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
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
Category: Multiple antinuclear antibody (ANA) screening IVD, reagent
Immco Diagnostics by Immco Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Immco Diagnostics, Inc.
Sources (1)
- FDA UDI 814e8239-a967-489d-b578-bdb1f44e941a 37 fields · synced Sep 17, 2026