Identity
- Trade Name
- Estrogen Receptor, Culture Supernatant with azide FDA UDI
- Generic Name
- Estrogen (oestrogen)/progesterone receptor IVD, kit, enzyme immunohistochemistry FDA UDI
- Model / Reference
- RM-9101-S0 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00673693402835 FDA UDI
- FDA Product Code
- MYA FDA UDI
- GMDN Term
- Estrogen (oestrogen)/progesterone receptor IVD, kit, enzyme immunohistochemistry 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
Yes
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
Category: Estrogen (oestrogen)/progesterone receptor IVD, kit, enzyme immunohistochemistry
Estrogen Receptor, Culture Supernatant with azide by Richard-Allan Scientific LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Estrogen (oestrogen)/progesterone receptor IVD, kit, enzyme immunohistochemistry.
- Progesterone Receptor Ready to use IHC (Quanto) — Richard-Allan Scientific LLC · Class II
- Epredia — Richard-Allan Scientific LLC · Class I
- Estrogen Receptor, Ready to use IHC (Quanto) — Richard-Allan Scientific LLC · Class II
- Estrogen Receptor, Culture Supernatant with azide — Richard-Allan Scientific LLC · Class II
- Epredia — Richard-Allan Scientific LLC · Class I
- Epredia — Richard-Allan Scientific LLC · Class I
- Epredia — Richard-Allan Scientific LLC · Class I
- Estrogen Receptor, Culture Supernatant with azide — Richard-Allan Scientific LLC · Class II
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
- Richard-Allan Scientific LLC
Sources (1)
- FDA UDI f0812734-4fc7-4afa-9807-be5ca1562ef6 32 fields · synced Jun 8, 2026