Identity
- Trade Name
- ihcDirect® Galectin-3 Ab-Enh 15mL FDA UDI
- Generic Name
- Galectin-3 IVD, antibody FDA UDI
- Device Name
- Clone R105 FDA UDI
- Model / Reference
- K47025-015 FDA UDI
- Description
- Clone R105 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850030934802 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- Galectin-3 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
Yes
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: Galectin-3 IVD, antibody
ihcDirect® Galectin-3 Ab-Enh 15mL by Novodiax, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Galectin-3 IVD, antibody.
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- BOND™ — Leica Biosystems Newcastle, Limited · Class I
- Galectin-3 — BIOCARE MEDICAL, LLC · Class I
- Mouse Monoclonal Anti-Human Galectin-3(MX060) Antibody — Fuzhou Maixin Biotech Co., Ltd. · Class I
- Mouse Monoclonal Anti-Human Galectin-3(MX060) Antibody — Fuzhou Maixin Biotech Co., Ltd. · Class I
- Galectin-3 (9C4) Mouse Monoclonal Antibody — CELL MARQUE CORPORATION · 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 c0f571e0-98d6-4507-97b1-7aadc22e47a6 36 fields · synced May 30, 2026