Identity
- Trade Name
- STAT-Site M Hgb Analyzer Pack FDA UDI
- Generic Name
- Haemoglobin analyser IVD, point-of-care FDA UDI
- Device Name
- The STAT-Site® M Hgb Meter is a dedicated reflectance photometer designed to accept only STAT-Site® M Hgb CODE Keys and STAT-Site® M Hgb Test Cards. This test system is intended for the quantitative determination of hemoglobin in the whole blood of adults, infants, and children in a physician’s office or other professional point-of-care setting. FDA UDI
- Model / Reference
- 900900 FDA UDI
- Description
- The STAT-Site® M Hgb Meter is a dedicated reflectance photometer designed to accept only STAT-Site® M Hgb CODE Keys and STAT-Site® M Hgb Test Cards. This test system is intended for the quantitative determination of hemoglobin in the whole blood of adults, infants, and children in a physician’s office or other professional point-of-care setting. FDA UDI
Identifiers
- Catalog Number
- 900900 FDA UDI
- Primary DI / UDI-DI
- 00657498000144 FDA UDI
- FDA Product Code
- KHG FDA UDI
- GMDN Term
- Haemoglobin analyser IVD, point-of-care FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.7500 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
STAT-Site M Hgb Analyzer Pack 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 c35ade7b-5acd-441c-8017-25cea17a6662 36 fields · synced May 30, 2026