Identity
- Trade Name
- ihcDirect® Pan-CK 4Abs FDA UDI
- Generic Name
- Cytokeratin IVD, kit, enzyme immunohistochemistry FDA UDI
- Device Name
- Clones AE1/AE3, C94, R226 FDA UDI
- Model / Reference
- K31058-015 FDA UDI
- Description
- Clones AE1/AE3, C94, R226 FDA UDI
Identifiers
- Catalog Number
- K31058-015 FDA UDI
- Primary DI / UDI-DI
- 00850000596214 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- Cytokeratin IVD, kit, enzyme immunohistochemistry FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.1860 FDA UDI
- Commercial Distribution
- Not 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
No
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
Dimensions & Sizes
- Size
- Total Volume — 15 Milliliter FDA UDI
ihcDirect® Pan-CK 4Abs by Novodiax, Inc. — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Novodiax, Inc.
Sources (1)
- FDA UDI 6dc2bc21-e441-4308-9ba4-6f1c3b5a9b33 38 fields · synced Jun 1, 2026