Identity
- Trade Name
- STAT-Site Hgb Controls FDA UDI
- Generic Name
- Total haemoglobin (totHb) IVD, control FDA UDI
- Device Name
- A bi-level reference control intended for use on STAT-Site® and HemoSite® hemoglobin testing systems, including the STAT-Site® MHgb Test System. FDA UDI
- Model / Reference
- 503000 FDA UDI
- Description
- A bi-level reference control intended for use on STAT-Site® and HemoSite® hemoglobin testing systems, including the STAT-Site® MHgb Test System. FDA UDI
Identifiers
- Catalog Number
- 503000 FDA UDI
- Primary DI / UDI-DI
- 00657498000168 FDA UDI
- FDA Product Code
- JPK FDA UDI
- GMDN Term
- Total haemoglobin (totHb) IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.8625 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
STAT-Site Hgb Controls by Stanbio Laboratory, L.p. — 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
- Stanbio Laboratory, L.p.
Sources (1)
- FDA UDI a7c05f2b-371d-4f69-9afe-8d7e296d82d5 37 fields · synced May 30, 2026