Identity
- Trade Name
- VENTANA CLDN18 (43-14A) RxDx Assay FDA UDI
- Generic Name
- Claudin protein IVD, antibody FDA UDI
- Model / Reference
- 08287066001 FDA UDI
Identifiers
- Catalog Number
- 08287066001 FDA UDI
- Primary DI / UDI-DI
- 07613336149201 FDA UDI
- PMA Number
- P230018 FDA UDI
- FDA Product Code
- QJZ FDA UDI
- GMDN Term
- Claudin protein IVD, antibody FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4100 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
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Claudin protein IVD, antibody
VENTANA CLDN18 (43-14A) RxDx Assay by Ventana Medical Systems — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Claudin protein IVD, antibody.
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- Rabbit Monoclonal Anti-Human Claudin-3 — EPITOMICS, INC. · Class I
- Rabbit Monoclonal Anti-Human Claudin-3 — EPITOMICS, INC. · Class I
- Rabbit Monoclonal Anti-Human Claudin-1, EP420 — EPITOMICS, INC. · Class I
- Rabbit Monoclonal Anti-Human Claudin-1, EP420 — EPITOMICS, INC. · Class I
- Claudin-4 — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Ventana Medical Systems
Sources (1)
- FDA UDI 4baf60a2-6a65-4553-97f4-2533ad6f8191 34 fields · synced Jun 8, 2026