Identity
- Trade Name
- ihcDirect® TROP2 Ab Conjugate 5mL FDA UDI
- Generic Name
- Trophoblast antigen 2 (TROP2) IVD, antibody FDA UDI
- Device Name
- R1011 FDA UDI
- Model / Reference
- H32044-R005 FDA UDI
- Description
- R1011 FDA UDI
Identifiers
- Catalog Number
- K32044-005 FDA UDI
- Primary DI / UDI-DI
- 00850030934819 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- Trophoblast antigen 2 (TROP2) IVD, antibody 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 — 5 Milliliter FDA UDI
Category: Trophoblast antigen 2 (TROP2) IVD, antibody
ihcDirect® TROP2 Ab Conjugate 5mL by Novodiax, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Trophoblast antigen 2 (TROP2) IVD, antibody.
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- Rabbit Monoclonal Anti-Human TACSTD2 — EPITOMICS, 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 730b18bf-e8f2-48ea-899c-2501d9c95ec4 37 fields · synced Jun 8, 2026