Identity
- Trade Name
- DRG:HYBRiD.XL® FDA UDI
- Generic Name
- Nephelometry/turbidimetry analyser IVD, automated/semi-automated FDA UDI
- Device Name
- The DRG:HYBRiD-XL® is a fully automated random access analyzer. The innovative technology of the DRG:HYBRiD-XL® allows users to simultaneously process immunoassays and clinical chemistry parameters, including turbidimetry, on one or more patient samples. The DRG:HYBRiD-XL® can be used for both the quantitative and qualitative (cut-off) evaluation of immunoassays. FDA UDI
- Model / Reference
- HYB-5252 FDA UDI
- Description
- The DRG:HYBRiD-XL® is a fully automated random access analyzer. The innovative technology of the DRG:HYBRiD-XL® allows users to simultaneously process immunoassays and clinical chemistry parameters, including turbidimetry, on one or more patient samples. The DRG:HYBRiD-XL® can be used for both the quantitative and qualitative (cut-off) evaluation of immunoassays. FDA UDI
Identifiers
- Catalog Number
- HYB-5252 FDA UDI
- Primary DI / UDI-DI
- 00404847452525 FDA UDI
- FDA Product Code
- JJQ FDA UDI
- GMDN Term
- Nephelometry/turbidimetry analyser IVD, automated/semi-automated FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2300 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
Yes
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
DRG:HYBRiD.XL® by DRG Instruments Gesellschaft mit beschränkter Haftung — Class I — 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 I | Pending data |
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Manufacturer
Sources (1)
- FDA UDI 08e9313b-1d8b-4960-97fd-d73226226bbd 37 fields · synced Jun 8, 2026