gudid
Primary ID: U621
URiSCAN 10 ACR strip (UDI U621)
Manufactured by YD Diagnostics CORP.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for URiSCAN 10 ACR strip - Primary ID U621
Device Regulatory Overview
The URiSCAN 10 ACR strip (Model/Catalog Number: U621) is a medical device manufactured by YD Diagnostics CORP.. This product is indexed under FDA Product Code / Category Classification LJX within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- U621
- Product Code / EMDN
- LJX
- Device Name
- Urinalysis dip and read strips for visual and URiSCAN urine analyzer.Test for Blood, Ketones(Acetoacetic Acid), Protein, Nitrite, Glucose, pH, SG(Specific Gravity), Leucocytes, Microalbumin and Creatinine in urine.
- Database Sync Date
- 2026-08-09 09:27:59
Full Regulatory Attributes
🔒 Token Gated
{
"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 URiSCAN 10 ACR strip?
The registered manufacturer of record for URiSCAN 10 ACR strip is YD Diagnostics CORP..
What is the Primary UDI-DI identifier for URiSCAN 10 ACR strip?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is U621.
What classification code is assigned to this device?
This device is registered under product classification code LJX.
Similar Classification Devices (LJX)
Other Devices by YD Diagnostics CORP.
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