gudid
Primary ID: 84679
Refractrol SP 6.0 Low (UDI 84679)
Manufactured by Lgc Clinical Diagnostics, Inc.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Refractrol SP 6.0 Low - Primary ID 84679
Device Regulatory Overview
The Refractrol SP 6.0 Low (Model/Catalog Number: 84679) is a medical device manufactured by Lgc Clinical Diagnostics, Inc.. This product is indexed under FDA Product Code / Category Classification JJX within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 84679
- Product Code / EMDN
- JJX
- Device Name
- Refractrol 6.0 Low and Refractrol 9.0 High are reference controls consisting of bovine serum albumin in a synthetic matrix. They are intended to estimate laboratory testing precision and can be used to detect errors in laboratory testing procedures for total serum protein values, as measured by digital and analog refractometer procedures. Refractrol 6.0 Low and Refractrol 9.0 High controls are provided with quantitative concentration values obtained by testing on multiple refractometry systems. For professional laboratory use only.
- Database Sync Date
- 2026-08-09 09:00:28
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 Refractrol SP 6.0 Low?
The registered manufacturer of record for Refractrol SP 6.0 Low is Lgc Clinical Diagnostics, Inc..
What is the Primary UDI-DI identifier for Refractrol SP 6.0 Low?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 84679.
What classification code is assigned to this device?
This device is registered under product classification code JJX.
Similar Classification Devices (JJX)
Other Devices by Lgc Clinical Diagnostics, Inc.
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