Identity
- Trade Name
- OpsisDx FDA UDI
- Generic Name
- Multiple-type clinical chemistry analyte profile IVD, calibrator FDA UDI
- Device Name
- Metal tray used for quality control of OpsisDx heater FDA UDI
- Model / Reference
- Quality Control Tray FDA UDI
- Description
- Metal tray used for quality control of OpsisDx heater FDA UDI
Identifiers
- Catalog Number
- ENT010 FDA UDI
- Primary DI / UDI-DI
- B550ENT0100 FDA UDI
- FDA Product Code
- NSU FDA UDI
- GMDN Term
- Multiple-type clinical chemistry analyte profile IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.2570 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
OpsisDx by Entopsis, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Entopsis, Llc
Sources (1)
- FDA UDI 61d71847-c051-4734-825c-be0ffa46eefd 35 fields · synced Jun 8, 2026