Identity
- Trade Name
- HemosIL Calcium Chloride 0.025M (for APTT-SP kit) FDA UDI
- Generic Name
- Calcium chloride coagulation reagent IVD FDA UDI
- Device Name
- HemosIL Calcium Chloride 0.025M (for APTT-SP kit) FDA UDI
- Model / Reference
- 00019741910 FDA UDI
- Description
- HemosIL Calcium Chloride 0.025M (for APTT-SP kit) FDA UDI
Identifiers
- Catalog Number
- 00019741910 FDA UDI
- Primary DI / UDI-DI
- 08426950023487 FDA UDI
- 510(k) Number
- K973306 FDA UDI
- FDA Product Code
- GFO FDA UDI
- GMDN Term
- Calcium chloride coagulation reagent IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.7925 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
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
HemosIL Calcium Chloride 0.025M (for APTT-SP kit) by Instrumentation Laboratory Company — Class II — FDA UDI — listed in FDA GUDID
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
- Instrumentation Laboratory Company
Sources (1)
- FDA UDI 37035d03-f626-4437-b8d7-01febb0f9b83 38 fields · synced Jun 8, 2026