DRG:HYBRiD.XL®
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- DRG:Hybrid-XL EUDAMEDDRG:HYBRiD.XL® FDA UDI
- Generic Name
- Enzyme immunoassay (EIA) analyser IVD FDA UDI
- Device Name
- DRG:Hybrid-XL EUDAMEDThe DRG:HYBRiD-XL® is a fully automated random access analyzer. FDA UDI
- Model / Reference
- HYB-5252 EUDAMEDFDA UDIDRG:Hybrid-XL EUDAMED
- Description
- The DRG:HYBRiD-XL® is a fully automated random access analyzer. FDA UDI
Identifiers
- Catalog Number
- HYB-5252 FDA UDI
- Primary DI / UDI-DI
- 04048474052527 EUDAMEDFDA UDI
- Basic UDI-DI
- 4048474HYB-5252KY EUDAMED
- FDA Product Code
- JJQ FDA UDI
- EMDN Code
- W0299 IVD INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Enzyme immunoassay (EIA) analyser IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2300 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
No
Microbial Substances
No
Reagent
No
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
Yes
New Device
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Enzyme immunoassay (EIA) analyser IVDNephelometry/turbidimetry analyser IVD, automated/semi-automated
DRG:HYBRiD.XL® by DRG Instruments Gesellschaft mit beschränkter Haftung — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Nephelometry/turbidimetry analyser IVD, automated/semi-automated.
- DRG:HYBRiD.XL® — DRG International, Inc. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
Sources (2)
- FDA UDI 6b42e3ee-6fea-474e-8da4-932a843c9310 36 fields · synced Jun 18, 2026
- EUDAMED cddbeddf-4be0-43d3-b0cd-0d91e7f0dde0 61 fields · synced Jun 18, 2026