Identity
- Trade Name
- HemoPoint® H2 n•x•t Microcuvettes FDA UDI
- Generic Name
- Haemoglobin analyser IVD, point-of-care FDA UDI
- Device Name
- For the quantitative determination of hemoglobin in capillary, venous or arterial whole blood. FDA UDI
- Model / Reference
- 3016-050 FDA UDI
- Description
- For the quantitative determination of hemoglobin in capillary, venous or arterial whole blood. FDA UDI
Identifiers
- Catalog Number
- 3016-050 FDA UDI
- Primary DI / UDI-DI
- 00657498301654 FDA UDI
- FDA Product Code
- GKR FDA UDI
- GMDN Term
- Haemoglobin analyser IVD, point-of-care FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.5620 FDA UDI
- Commercial Distribution
- 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
Category: Haemoglobin analyser IVD, point-of-care
HemoPoint® H2 n•x•t Microcuvettes by Stanbio Laboratory, L.p. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Haemoglobin analyser IVD, point-of-care.
- HemoCue® Hb 801 Microcuvettes — Hemocue, Inc. · Class II
- HemoCue® Hb 201 Microcuvettes — Hemocue, Inc. · Class II
- HemoCue® Hb301 Analyzer — Hemocue, Inc. · Class II
- HemoCue® Hb301 Analyzer — Hemocue, Inc. · Class II
- DiaSpect Tm — EKF-diagnostic GmbH · Class II
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class II
- HemoCue® Hb 201 Microcuvettes — Hemocue, Inc. · Class II
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class II
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 45835534-4852-40e6-a8c9-156b3c04d3d5 36 fields · synced May 30, 2026