Pointe Uric Acid Reagent (UDI 16-HU982-308)
Manufactured by HORIBA INSTRUMENTS INCORPORATED
Device Regulatory Overview
The Pointe Uric Acid Reagent (Model/Catalog Number: 16-HU982-308) is a medical device manufactured by HORIBA INSTRUMENTS INCORPORATED. This product is indexed under FDA Product Code / Category Classification KNK within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 16-HU982-308
- Product Code / EMDN
- KNK
- 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.
- Database Sync Date
- 2026-08-09 09:22:13
Full Regulatory Attributes
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{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of Pointe Uric Acid Reagent?
The registered manufacturer of record for Pointe Uric Acid Reagent is HORIBA INSTRUMENTS INCORPORATED.
What is the Primary UDI-DI identifier for Pointe Uric Acid Reagent?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 16-HU982-308.
What classification code is assigned to this device?
This device is registered under product classification code KNK.
Similar Classification Devices (KNK)
Other Devices by HORIBA INSTRUMENTS INCORPORATED
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