SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706 (UDI Z-0441-2026)
Manufactured by Beckman Coulter Inc.
Device Regulatory Overview
The SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706 (Model/Catalog Number: Unspecified) is a medical device manufactured by Beckman Coulter Inc.. This product is indexed under FDA Product Code / Category Classification REF: 969706. Lot: M404166. Expiration Date: 30Nov2025 within international Unique Device Identification (UDI) compliance databases.
Enforcement actions are currently active for this product line.
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Technical Specifications
- Model Number
- N/A
- Product Code / EMDN
- REF: 969706. Lot: M404166. Expiration Date: 30Nov2025
- Device Name
- SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706
- Database Sync Date
- 2026-08-09 10:06:32
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 SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706?
The registered manufacturer of record for SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706 is Beckman Coulter Inc..
What is the Primary UDI-DI identifier for SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is Z-0441-2026.
What classification code is assigned to this device?
This device is registered under product classification code REF: 969706. Lot: M404166. Expiration Date: 30Nov2025.
Other Devices by Beckman Coulter Inc.
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