Identity
- Trade Name
- Dxpress Reader FDA UDI
- Generic Name
- Microplate reader IVD, semi-automated FDA UDI
- Device Name
- Dxpress Reader/1 Unit FDA UDI
- Model / Reference
- LSR-2000 FDA UDI
- Description
- Dxpress Reader/1 Unit FDA UDI
Identifiers
- Catalog Number
- LSR-2000-00 FDA UDI
- Primary DI / UDI-DI
- 10743816001362 FDA UDI
- 510(k) Number
- K050955 FDA UDI
- FDA Product Code
- JJQ FDA UDI
- GMDN Term
- Microplate reader IVD, semi-automated FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2300 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Microplate reader IVD, semi-automated
Dxpress Reader by Princeton Biomeditech Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Microplate reader IVD, semi-automated.
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
- Princeton Biomeditech Corp.
Sources (1)
- FDA UDI 318e6b79-8168-4167-9bfd-48c30ea881ea 37 fields · synced May 29, 2026