Identity
- Trade Name
- Sprinter XL (model 160 samples, IFA/ELISA incl. Incubator) FDA UDI
- Generic Name
- Enzyme immunoassay (EIA) analyser IVD FDA UDI
- Model / Reference
- YG 0033-0101-3 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04049016109686 FDA UDI
- FDA Product Code
- JJE FDA UDI
- GMDN Term
- Enzyme immunoassay (EIA) analyser IVD FDA UDI
- Models / Variants
- model 160 samples FDA UDIIFA FDA UDIELISA incl. Incubator FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2160 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Sprinter XL - model 160 samples by EUROIMMUN Medizinische Labordiagnostika AG — Class I — FDA UDI — listed in FDA GUDID — 3 models
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
- Manufacturer
- EUROIMMUN Medizinische Labordiagnostika AG
Sources (1)
- FDA UDI 1d9555a3-8344-4c96-8da0-59c7586343f3 33 fields · synced May 30, 2026