HDL Cholesterol Reagent (HDL 2 x 200), Catalog No. A15625. Intended for quantitative determination of HDL cholesterol in the high density lipoprotein fraction of human serum or plasma. (UDI Z-2082-2017)
Manufactured by Beckman Coulter Inc.
Device Regulatory Overview
The HDL Cholesterol Reagent (HDL 2 x 200), Catalog No. A15625. Intended for quantitative determination of HDL cholesterol in the high density lipoprotein fraction of human serum or plasma. (Model/Catalog Number: Unspecified) is a medical device manufactured by Beckman Coulter Inc.. This product is indexed under FDA Product Code / Category Classification all lots 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
- all lots
- Device Name
- HDL Cholesterol Reagent (HDL 2 x 200), Catalog No. A15625. Intended for quantitative determination of HDL cholesterol in the high density lipoprotein fraction of human serum or plasma.
- Database Sync Date
- 2026-08-09 10:06:40
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 HDL Cholesterol Reagent (HDL 2 x 200), Catalog No. A15625. Intended for quantitative determination of HDL cholesterol in the high density lipoprotein fraction of human serum or plasma.?
The registered manufacturer of record for HDL Cholesterol Reagent (HDL 2 x 200), Catalog No. A15625. Intended for quantitative determination of HDL cholesterol in the high density lipoprotein fraction of human serum or plasma. is Beckman Coulter Inc..
What is the Primary UDI-DI identifier for HDL Cholesterol Reagent (HDL 2 x 200), Catalog No. A15625. Intended for quantitative determination of HDL cholesterol in the high density lipoprotein fraction of human serum or plasma.?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is Z-2082-2017.
What classification code is assigned to this device?
This device is registered under product classification code all lots.
Similar Classification Devices (all lots)
- → Lactate Reagent (LACT 2 x 50), Catalog No. A95550 Intended for the quantitative determination of Lactate concentration in human plasma and cerebrospinal fluid (CSF).
- → AIA-PACK Folate (FOL) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of folate in human serum on Tosoh AIA System analyzers.
- → Triglycerides Reagent (TG 2 x 300), Catalog No. 445850. Intended for quantitative determination of triglycerides concentration in human serum or plasma.
- → Cholesterol Reagent(CHOL 2 x 300), Catalog No. 467825 Intended for quantitative determination of cholesterol concentration in human serum or plasma.
Other Devices by Beckman Coulter Inc.
- → SYNCHRON Systems Phosphorus (PHOSm) Reagent REF: 467868 For In Vitro Diagnostic Use, Rx Only.
- → SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706
- → DxC 500 AU Module w/ISE, DxC 500i, With ISE, REF: C63522 and DxC 500 AU Module, DxC 500i, Without ISE, REF: C6352; part of the DxC 500i Clinical Analyzer
- → UIBC (Unsaturated Iron Binding Capacity), REF: OSR61205,
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