Identity
- Trade Name
- PolyTiter FDA UDI
- Generic Name
- Multiple antinuclear antibody (ANA) screening IVD, calibrator FDA UDI
- Device Name
- Anti Nuclear Antibody, Calibrator, PolyTiter FDA UDI
- Model / Reference
- ANA-CAL FDA UDI
- Description
- Anti Nuclear Antibody, Calibrator, PolyTiter FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00855574005360 FDA UDI
- FDA Product Code
- DHN FDA UDI
- GMDN Term
- Multiple antinuclear antibody (ANA) screening IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5100 FDA UDI
- Commercial Distribution
- Not 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
PolyTiter by Polymedco, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Polymedco, Inc.
Sources (1)
- FDA UDI 66ab1fc7-60c6-4a20-998e-3b3e107dd6c6 35 fields · synced Jun 1, 2026