FDA.reportPublic FDA data

EON 300 HDL CHOLESTEROL REAGENT

Primary DI
03661540200557
Brand
EON 300 HDL CHOLESTEROL REAGENT
Company
VITALSCIENTIFIC
Model
79301
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03661540200557PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03661540200557036615402005573661540200557

GMDN Terms#

Term, Definition table
TermDefinition
High density lipoprotein (HDL) cholesterol IVD, kit, enzyme spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of high density lipoprotein (HDL) cholesterol lipid in a clinical specimen, using an enzyme spectrophotometry method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
267732378
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03661540214707GAMMA-GT SZASZ SLGZSL-02502016-09-24
03701700817802ELICAL 2 CALI-05502026-03-04
03701700819400ELITROL ICONT-00602026-03-04
03701700819509ELITROL IICONT-01602026-03-04
03701700800347LDL CALIBRATOR KIT551152026-02-12
03701700800354HDL CALIBRATOR KIT551192026-02-12
03701700821106HbA1c CALIBRATOR SET HBAC-00432026-01-19
03701700821205HbA1c CONTROL L+ HHBAC-00492026-01-19
03701700800019ENVOY 500 ALBUMIN REAGENT KIT552252025-03-31
03701700815006ALBUMINALBU-02502025-03-31
03701700800026ENVOY 500 ALT REAGENT KIT552152025-03-31
03701700800033ENVOY 500 AMYLASE REAGENT KIT552452025-03-31
03701700800040ENVOY 500 AST REAGENT KIT552502025-03-31
03701700800057ENVOY 500 URIC ACID REAG.KIT554502025-03-31
03701700800064ENVOY 500 DIRECT BILIRUBIN REAGENT KIT552602025-03-31
03701700800071ENVOY 500 TOTAL BILIRUBIN REAGENT KIT552702025-03-31
03701700800088ENVOY 500 CALCIUM REAGENT KIT552872025-03-31
03701700800095ENVOY 500 SERUM CALIBRATOR KIT551112025-03-31
03701700800101ENVOY 500 CHOLESTEROL REAGENT KIT552972025-03-31
03701700800125ENVOY 500 SERUM CONTROL KIT551312025-03-31