Identity
- Trade Name
- Mono Mo A-Hu Progesterone Receptor, Cl PgR 636 FDA UDI
- Generic Name
- Estrogen (oestrogen)/progesterone receptor IVD, antibody FDA UDI
- Device Name
- Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636 FDA UDI
- Model / Reference
- M3569 FDA UDI
- Description
- Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05700571102305 FDA UDI
- 510(k) Number
- K020023 FDA UDI
- FDA Product Code
- MXZ FDA UDI
- GMDN Term
- Estrogen (oestrogen)/progesterone receptor IVD, antibody FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.1860 FDA UDI
- Commercial Distribution
- Not 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 — 1 Milliliter FDA UDI
Mono Mo A-Hu Progesterone Receptor, Cl PgR 636 by Agilent Technologies Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K020023 also covers:
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
- Agilent Technologies Inc.
Sources (1)
- FDA UDI 54cb49fe-9de4-4bf7-a3a8-35a91f7e8be4 38 fields · synced May 31, 2026