Identity
- Trade Name
- ACE FDA UDI
- Generic Name
- Uric acid IVD, reagent FDA UDI
- Device Name
- Uric Acid Reagent FDA UDI
- Model / Reference
- RX1025 FDA UDI
- Description
- Uric Acid Reagent FDA UDI
Identifiers
- Catalog Number
- RX1025 FDA UDI
- Primary DI / UDI-DI
- 00857969006464 FDA UDI
- 510(k) Number
- K113389 FDA UDI
- FDA Product Code
- KNK FDA UDI
- GMDN Term
- Uric acid IVD, reagent FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1775 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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: Uric acid IVD, reagent
Ace by Alfa Wassermann, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Uric acid IVD, reagent.
- URIC ACID REAGENT KIT（URICASE METHOD） — DIRUI INDUSTRIAL CO., LTD · IVD General
- BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class I
- Uric Acid (UA) — Maccura Biotechnology Co., Ltd. · IVD General
- Liquick Cor-UA 120 — PZ CORMAY Spółka Akcyjna · IVD General
- URIC ACID Kit — KİNETİK BİLİŞİM DİAGNOSTİK ANONİM ŞİRKETİ · IVD General
- BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class I
- JAS Diagnostics — Drew Scientific , Ltd. · Class I
- Uric acid — Kalians Corporation · IVD General
Cleared under the same submission
K113389 also covers:
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
- Alfa Wassermann, Inc.
Sources (1)
- FDA UDI c5919b3f-0cfd-4bb6-a4bd-1acaa116a373 37 fields · synced May 30, 2026