Identity
- Trade Name
- Anti-PR (Insite) FDA UDI
- Generic Name
- Progesterone receptor IVD, antibody FDA UDI
- Model / Reference
- AM328-5M FDA UDI
Identifiers
- Catalog Number
- AM328-5M FDA UDI
- Primary DI / UDI-DI
- 00850646007013 FDA UDI
- 510(k) Number
- K012960 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
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
No
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 — 6 Milliliter FDA UDI
Category: Progesterone receptor IVD, antibody
Anti-PR (Insite) by Biogenex Laboratories, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- QSX-Enh-P PR (ASR) — NOVODIAX, INC. · Class I
- CONFIRM antiProgesterone Receptor PR 1E2 Rabbit Monoclonal Primary Antibody — Ventana Medical Systems · Class II
- Genemed® — Sakura Finetek USA, Inc · Class I
- Rabbit Monoclonal Anti-Human Progesterone Receptor Antibody, EP2 — EPITOMICS, INC. · Class I
- Rabbit Monoclonal Anti-Human Progesterone Receptor Antibody, EP2 — EPITOMICS, INC. · Class I
Cleared under the same submission
K012960 also covers:
- Anti-PR — Biogenex Laboratories, Inc.
- Anti-PR (Insite) — Biogenex Laboratories, Inc.
- Anti-PR (Insite) — Biogenex Laboratories, Inc.
- Anti-PR (Insite) — Biogenex Laboratories, Inc.
- Anti-PR (Insite) — Biogenex Laboratories, Inc.
- Anti-PR (Insite) — Biogenex Laboratories, Inc.
- Anti-PR (Insite) — Biogenex Laboratories, Inc.
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
- Biogenex Laboratories, Inc.
Sources (1)
- FDA UDI 69317534-bc5b-4296-ba9a-e80e8be39c07 37 fields · synced May 30, 2026