← Back to catalogue
CONFIRM antiProgesterone Receptor PR 1E2 Rabbit Monoclonal Primary Antibody
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- CONFIRM antiProgesterone Receptor PR 1E2 Rabbit Monoclonal Primary Antibody FDA UDI
- Generic Name
- Progesterone receptor IVD, antibody FDA UDI
- Model / Reference
- 50 tests FDA UDI
Identifiers
- Catalog Number
- 05277990001 FDA UDI
- Primary DI / UDI-DI
- 04015630972180 FDA UDI
- FDA Product Code
- MXZ FDA UDI
- GMDN Term
- Progesterone receptor IVD, antibody FDA UDI
Classification
- Device Class
- Class II 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
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: Progesterone receptor IVD, antibody
CONFIRM antiProgesterone Receptor PR 1E2 Rabbit Monoclonal Primary Antibody by Ventana Medical Systems — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Progesterone receptor IVD, antibody.
- Rabbit Monoclonal Anti-Human Progesterone Receptor Antibody, EP2 — EPITOMICS, INC. · Class I
- Rabbit Monoclonal Anti-Human Progesterone Receptor Antibody, EP2 — EPITOMICS, INC. · Class I
- Genemed® — Sakura Finetek USA, Inc · Class I
- Anti-PR (Insite) — Biogenex Laboratories, Inc. · Class II
- QSX-Enh-P PR (ASR) — NOVODIAX, INC. · Class I
- Anti-PR (Insite) — Biogenex Laboratories, Inc. · Class II
- Anti-PR (Insite) — Biogenex Laboratories, Inc. · Class II
- Genemed® — Sakura Finetek USA, 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ventana Medical Systems
Sources (1)
- FDA UDI a32ee454-cd04-4377-ade7-3f725a4e30dd 33 fields · synced May 29, 2026