Identity
- Trade Name
- Insulin FDA UDI
- Generic Name
- Insulin IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The DRG:HYBRId-XL Insulin is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of Insulin in serum and plasma (EDTA and Heparin). FDA UDI
- Model / Reference
- HYE-5361 FDA UDI
- Description
- The DRG:HYBRId-XL Insulin is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of Insulin in serum and plasma (EDTA and Heparin). FDA UDI
Identifiers
- Catalog Number
- HYE-5361 FDA UDI
- Primary DI / UDI-DI
- 00404847453614 FDA UDI
- FDA Product Code
- CFP FDA UDI
- GMDN Term
- Insulin IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1405 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Insulin 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
Sources (1)
- FDA UDI a203a023-b206-4ab5-ae5a-5b5f96e9147d 37 fields · synced May 30, 2026