Identity
- Trade Name
- IF Sprinter FDA UDI
- Generic Name
- Multichannel immunoassay analyser IVD FDA UDI
- Model / Reference
- YG 0032-0101 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04049016100577 FDA UDI
- FDA Product Code
- JQW FDA UDIJJE FDA UDI
- GMDN Term
- Multichannel immunoassay analyser IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2750 FDA UDI862.2160 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Multichannel immunoassay analyser IVD
IF Sprinter by EUROIMMUN Medizinische Labordiagnostika AG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Multichannel immunoassay analyser IVD.
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- Sprinter XL — EUROIMMUN Medizinische Labordiagnostika AG · Class I
- EUROLabWorkstation IFA — EUROIMMUN Medizinische Labordiagnostika AG · Class I
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
- EUROIMMUN Medizinische Labordiagnostika AG
Sources (1)
- FDA UDI 7c5e5c71-8622-4b01-98e5-737a9a02010d 32 fields · synced May 30, 2026