Identity
- Trade Name
- HemoCue® Albumin 201 Analyzer FDA UDI
- Generic Name
- Urine analyser IVD, point-of-care FDA UDI
- Device Name
- HemoCue Albumin 201 Analyzer mg/L FDA UDI
- Model / Reference
- 120623 FDA UDI
- Description
- HemoCue Albumin 201 Analyzer mg/L FDA UDI
Identifiers
- Catalog Number
- 120623 FDA UDI
- Primary DI / UDI-DI
- 07311091206237 FDA UDI
- FDA Product Code
- KQO FDA UDI
- GMDN Term
- Urine analyser IVD, point-of-care FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2900 FDA UDI
- Commercial Distribution
- 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Urine analyser IVD, point-of-care
HemoCue® Albumin 201 Analyzer by Hemocue, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Urine analyser IVD, point-of-care.
- Rapid Response — BTNX Inc · Class I
- AIMSTRIP URINE ANALYZER — GERMAINE LABORATORIES, INC. · Class I
- CLINITEK Status® Connector — Siemens Healthcare Diagnostics · Class I
- Rapid Response — BTNX Inc · Class I
- Mission U120 Urine Analyzer — ACON Laboratories, Inc. · Class I
- Rapid Response — BTNX Inc · Class I
- Mission U120 Urine Analyzer — ACON Laboratories, Inc. · Class I
- My Yodoc — S-CONNECT CO., LTD · Class I
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hemocue, Inc.
Sources (1)
- FDA UDI e78eba27-1836-4512-bef9-be4294cff29d 35 fields · synced Jun 1, 2026