Identity
- Trade Name
- SpinCon FDA UDI
- Generic Name
- Faecal parasite isolation kit IVD FDA UDI
- Device Name
- Para-Pak SpinCon is a unique, patented system for the concentration of parasite eggs, larvae, and protozoa from preserved fecal specimens. Specimens preserved in 10% Formalin, Sodium Acetate Formalin (SAF) and EcoFix may be used with this system. FDA UDI
- Model / Reference
- 972500 FDA UDI
- Description
- Para-Pak SpinCon is a unique, patented system for the concentration of parasite eggs, larvae, and protozoa from preserved fecal specimens. Specimens preserved in 10% Formalin, Sodium Acetate Formalin (SAF) and EcoFix may be used with this system. FDA UDI
Identifiers
- Catalog Number
- 972500 FDA UDI
- Primary DI / UDI-DI
- 00840733102424 FDA UDI
- FDA Product Code
- LKS FDA UDI
- GMDN Term
- Faecal parasite isolation kit IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.2900 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
SpinCon by Meridian Bioscience, Inc. — 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
- Manufacturer
- Meridian Bioscience, Inc.
Sources (1)
- FDA UDI d016b6a5-3cfb-4412-b5ec-dcf3d9a8c82b 37 fields · synced May 30, 2026