Identity
- Trade Name
- Albustix® Reagent Strips FDA UDI
- Generic Name
- Urine protein IVD, kit, rapid colorimetric, clinical FDA UDI
- Device Name
- ALBUSTIX® are intended for in vitro diagnostic use by healthcare professionals to detect the presence of protein in urine. FDA UDI
- Model / Reference
- 10333485 FDA UDI
- Description
- ALBUSTIX® are intended for in vitro diagnostic use by healthcare professionals to detect the presence of protein in urine. FDA UDI
Identifiers
- Catalog Number
- A2191B16 FDA UDI
- Primary DI / UDI-DI
- 00630414550602 FDA UDI
- 510(k) Number
- K992257 FDA UDI
- FDA Product Code
- JIL FDA UDIJIN FDA UDIJRE FDA UDIJMT FDA UDIJIO FDA UDICDM FDA UDIJIR FDA UDIJJB FDA UDIJFY FDA UDILJX FDA UDICEN FDA UDI
- GMDN Term
- Urine protein IVD, kit, rapid colorimetric, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1340 FDA UDI862.1435 FDA UDI862.2800 FDA UDI862.1510 FDA UDI864.6550 FDA UDI862.1785 FDA UDI862.1645 FDA UDI862.1115 FDA UDI862.1225 FDA UDI864.7675 FDA UDI862.1550 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
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
Category: Urine protein IVD, kit, rapid colorimetric, clinical
Albustix® Reagent Strips by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K992257 also covers:
- Azostix® Reagent Strips — Siemens Healthcare Diagnostics
- Combistix® Reagent Strips — Siemens Healthcare Diagnostics
- Hema-Combistix® Reagent Strips — Siemens Healthcare Diagnostics
- Multistix PRO® 10LS Reagent Strips — Siemens Healthcare Diagnostics
- Multistix PRO® 10LS Reagent Strips — Siemens Healthcare Diagnostics
- Multistix® 10 SG Reagent Strips — Siemens Healthcare Diagnostics
- Multistix® 7 Reagent Strips — Siemens Healthcare Diagnostics
- Multistix® 8 SG Reagent Strips — Siemens Healthcare Diagnostics
- Multistix® 9 Reagent Strips — Siemens Healthcare Diagnostics
- Multistix® 9 SG Reagent Strips — Siemens Healthcare Diagnostics
- Multistix® Reagent Strips — Siemens Healthcare Diagnostics
- Uristix® 4 Reagent Strips — Siemens Healthcare Diagnostics
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
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI 819ef18f-3813-4a41-b439-2576db12c4ad 37 fields · synced Jun 1, 2026