Identity
- Trade Name
- ihcDirect® CDX2 Ab Conjugate 15mL FDA UDI
- Generic Name
- Homeobox protein CDX-2 IVD, kit, enzyme immunohistochemistry FDA UDI
- Device Name
- Clone R1014 FDA UDI
- Model / Reference
- H32047-R015 FDA UDI
- Description
- Clone R1014 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850030934864 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- Homeobox protein CDX-2 IVD, kit, enzyme immunohistochemistry FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.1860 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
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
Category: Homeobox protein CDX-2 IVD, kit, enzyme immunohistochemistry
ihcDirect® CDX2 Ab Conjugate 15mL by Novodiax, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Homeobox protein CDX-2 IVD, kit, enzyme immunohistochemistry.
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- ihcDirect® CDX2 Ab Conjugate 5mL — NOVODIAX, INC. · Class I
- Q-STAIN® QSX-Enh-F CDX2 — NOVODIAX, INC. · Class I
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 f38e2fa5-3607-4c15-9e87-cf458c120c40 36 fields · synced May 30, 2026