Identity
- Trade Name
- JAS Diagnostics FDA UDI
- Generic Name
- Uric acid IVD, reagent FDA UDI
- Device Name
- URIC ACID LIQ BULK (in 20L cub) FDA UDI
- Model / Reference
- URI2-BUL FDA UDI
- Description
- URIC ACID LIQ BULK (in 20L cub) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817274022153 FDA UDI
- 510(k) Number
- K012038 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Uric acid IVD, reagent
JAS Diagnostics by Drew Scientific , Ltd. — 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
- Uric acid — Kalians Corporation · IVD General
- ACE — Alfa Wassermann, Inc. · Class I
Cleared under the same submission
K012038 also covers:
- JAS Diagnostics — Drew Scientific , Ltd.
- JAS Diagnostics — Drew Scientific , Ltd.
- JAS Diagnostics — Drew Scientific , Ltd.
- JAS Diagnostics — Drew Scientific , Ltd.
- JAS Diagnostics — Drew Scientific , Ltd.
- JAS Diagnostics — Drew Scientific , Ltd.
- JAS Diagnostics — Drew Scientific , Ltd.
- JAS Diagnostics — Drew Scientific , Ltd.
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
- Drew Scientific , Ltd.
Sources (1)
- FDA UDI 794d576f-d74b-4b37-ab0a-1cb113115b06 36 fields · synced May 30, 2026