Identity
- Trade Name
- Pointe Scientific, Inc. FDA UDI
- Generic Name
- Uric acid IVD, reagent FDA UDI
- Device Name
- Uric Acid Reagent, for the quantitative determination of Uric Acid in serum. For in vitro diagnostic use only. Size: 1 x 500 mL FDA UDI
- Model / Reference
- 13-U7581-500 FDA UDI
- Description
- Uric Acid Reagent, for the quantitative determination of Uric Acid in serum. For in vitro diagnostic use only. Size: 1 x 500 mL FDA UDI
Identifiers
- Catalog Number
- 13-U7581-500 FDA UDI
- Primary DI / UDI-DI
- 00811727014467 FDA UDI
- 510(k) Number
- K970560 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
Yes
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
Pointe Scientific, Inc. by Pointe Scientific, 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
K970560 also covers:
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. Uric Acid — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. Uric Acid — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. Uric Acid — POINTE SCIENTIFIC, INC.
- Pointe Uric Acid Reagent — POINTE SCIENTIFIC, INC.
- Pointe Uric Acid Reagent — POINTE SCIENTIFIC, INC.
- Uric Acid — POINTE SCIENTIFIC, INC.
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
- Pointe Scientific, Inc.
Sources (1)
- FDA UDI a82882fb-1646-42d9-86e1-211261121be2 37 fields · synced Jun 8, 2026