Identity
- Trade Name
- CytoCell FDA UDI
- Generic Name
- Assay development analyte-specific reagent IVD FDA UDI
- Device Name
- TFE3 Proximal Probe Red FDA UDI
- Model / Reference
- LPS522-A FDA UDI
- Description
- TFE3 Proximal Probe Red FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05055844901469 FDA UDI
- FDA Product Code
- MVU FDA UDI
- GMDN Term
- Assay development analyte-specific reagent IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.4020 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Assay development analyte-specific reagent IVD
CytoCell's TFE3 Proximal Probe Red is a medical device designed for laboratory use. This device features a sterile design, with no labeling as an implantable device or specific to the prostate gland.
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Cytocell, Ltd.
Sources (1)
- FDA UDI e23e1ae6-53f0-4f12-9b33-460cd1fa71b1 35 fields · synced Jun 29, 2026