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SteriChek® Blood Leak Reagent Strips
FDA UDIClass II (US FDA UDI)
by Hach Company
Identity
- Trade Name
- SteriChek® Blood Leak Reagent Strips FDA UDI
- Generic Name
- Haemodialysis system blood leak detector FDA UDI
- Device Name
- Reagent test strips used to test for the presence of blood in dialysate fluid during the hemodialysis procedure. FDA UDI
- Model / Reference
- 812014 FDA UDI
- Description
- Reagent test strips used to test for the presence of blood in dialysate fluid during the hemodialysis procedure. FDA UDI
Identifiers
- Catalog Number
- 812014 FDA UDI
- Primary DI / UDI-DI
- 00851575007105 FDA UDI
- FDA Product Code
- FJD FDA UDI
- GMDN Term
- Haemodialysis system blood leak detector FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5820 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Width — 0.2 Inch FDA UDILength — 3.25 Inch FDA UDI
SteriChek® Blood Leak Reagent Strips by Hach Company — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Hach Company
Sources (1)
- FDA UDI ed6ed2cf-ea2f-4689-bb2c-a06c8133314c 38 fields · synced Jun 1, 2026