Identity
- Trade Name
- Anti- HER2/ERBB2 PHOSPHO (PY877) FDA UDI
- Generic Name
- Human epidermal growth factor receptor 2 (HER2) protein IVD, antibody FDA UDI
- Model / Reference
- NU726-UC FDA UDI
Identifiers
- Catalog Number
- NU726-UC FDA UDI
- Primary DI / UDI-DI
- 00810119677433 FDA UDI
- FDA Product Code
- MVU FDA UDI
- GMDN Term
- Human epidermal growth factor receptor 2 (HER2) protein IVD, antibody FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.4020 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 — 1 Milliliter FDA UDI
Category: Human epidermal growth factor receptor 2 (HER2) protein IVD, antibody
Anti- HER2/ERBB2 PHOSPHO (PY877) by Biogenex Laboratories, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- HER2 neu Phospho RMab — BIO SB, INC. · Class I
- HER2 neu Phospho RMab — BIO SB, INC. · Class I
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- c-erbB-2/HER2 — BIOCARE MEDICAL, LLC · 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
- Biogenex Laboratories, Inc.
Sources (1)
- FDA UDI ed5884c8-b73a-434b-8703-e4c1d28f5182 36 fields · synced May 30, 2026