Identity
- Trade Name
- ISOSTAT® Consumables FDA UDI
- Generic Name
- Fluid transfer set, general-purpose FDA UDI
- Device Name
- Consumables needed for processing ISOLATOR 10 mL Microbial Tubes for adults. FDA UDI
- Model / Reference
- 50C9 FDA UDI
- Description
- Consumables needed for processing ISOLATOR 10 mL Microbial Tubes for adults. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10811877010064 FDA UDI
- 510(k) Number
- K840496 FDA UDI
- FDA Product Code
- JKA FDA UDI
- GMDN Term
- Fluid transfer set, general-purpose FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1675 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Fluid transfer set, general-purpose
ISOSTAT® Consumables by Alere Scarborough, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 II | Pending data |
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Manufacturer
- Manufacturer
- Alere Scarborough, Inc.
Sources (1)
- FDA UDI 7d27aebf-f32a-4304-a515-65956943dc5e 35 fields · synced May 31, 2026