Identity
- Trade Name
- Azostix® Reagent Strips FDA UDI
- Generic Name
- Urea IVD, kit, enzyme spectrophotometry FDA UDI
- Device Name
- AZOSTIX® is a firm, plastic strip to which is affixed an impregnated reagent area for estimating the amount of urea nitrogen in whole blood to provide information on renal function. FDA UDI
- Model / Reference
- 10324060 FDA UDI
- Description
- AZOSTIX® is a firm, plastic strip to which is affixed an impregnated reagent area for estimating the amount of urea nitrogen in whole blood to provide information on renal function. FDA UDI
Identifiers
- Catalog Number
- A2830C16 FDA UDI
- Primary DI / UDI-DI
- 00630414551142 FDA UDI
- 510(k) Number
- K992257 FDA UDI
- FDA Product Code
- JMT FDA UDIJFY FDA UDIJIL FDA UDICDM FDA UDILJX FDA UDIJIN FDA UDIJIR FDA UDICEN FDA UDIJIO FDA UDIJRE FDA UDIJJB FDA UDI
- GMDN Term
- Urea IVD, kit, enzyme spectrophotometry FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1510 FDA UDI862.1225 FDA UDI862.1340 FDA UDI862.1785 FDA UDI864.7675 FDA UDI862.1435 FDA UDI862.1645 FDA UDI862.1550 FDA UDI864.6550 FDA UDI862.2800 FDA UDI862.1115 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: Urea IVD, kit, enzyme spectrophotometry
Azostix® Reagent Strips by Siemens Healthcare Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Urea IVD, kit, enzyme spectrophotometry.
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- POINTE SCIENTIFIC BUN Liquid — POINTE SCIENTIFIC, INC. · Class II
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- POINTE SCIENTIFIC BUN Liquid — POINTE SCIENTIFIC, INC. · Class II
Cleared under the same submission
K992257 also covers:
- Albustix® Reagent Strips — Siemens Healthcare Diagnostics
- Combistix® Reagent Strips — Siemens Healthcare Diagnostics
- Hema-Combistix® Reagent Strips — Siemens Healthcare Diagnostics
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- 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 I | Pending data |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI 62a97647-281a-4f37-9fc0-22e1e91e5c41 37 fields · synced May 30, 2026