Identity
- Trade Name
- Pointe Uric Acid Reagent FDA UDI
- Generic Name
- Uric acid IVD, reagent FDA UDI
- Device Name
- Pointe Uric Acid Reagent packaged for use on the Mindray BA800. 4 x 65ml R1, 3 x 16ml R2. For the quantitative determination of uric acid in serum. For in vitro diagnostic use only. FDA UDI
- Model / Reference
- 16-HU982-308 FDA UDI
- Description
- Pointe Uric Acid Reagent packaged for use on the Mindray BA800. 4 x 65ml R1, 3 x 16ml R2. For the quantitative determination of uric acid in serum. For in vitro diagnostic use only. FDA UDI
Identifiers
- Catalog Number
- 16-HU982-308 FDA UDI
- Primary DI / UDI-DI
- 00811727016294 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 Uric Acid Reagent by Pointe Scientific, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Uric acid IVD, reagent.
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- 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. — 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.
- 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 |
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Manufacturer
- Manufacturer
- Pointe Scientific, Inc.
Sources (1)
- FDA UDI 31de2eda-bbce-44ea-b52a-a8619fcf2d45 37 fields · synced May 30, 2026