CHOLESTEROL LDL 2G CALIBRATOR

GUDID 03701700824503

VITALSCIENTIFIC

Low density lipoprotein (LDL) cholesterol IVD, calibrator
Primary Device ID03701700824503
NIH Device Record Key53c15b67-f66e-4b88-b5a3-3d863907e737
Commercial Distribution StatusIn Commercial Distribution
Brand NameCHOLESTEROL LDL 2G CALIBRATOR
Version Model NumberLDLL-0041
Company DUNS267732378
Company NameVITALSCIENTIFIC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS103701700824503 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-04-08
Device Publish Date2025-03-31

Devices Manufactured by VITALSCIENTIFIC

03701700800019 - ENVOY 500 ALBUMIN REAGENT KIT2025-04-08
03701700800026 - ENVOY 500 ALT REAGENT KIT2025-04-08
03701700800033 - ENVOY 500 AMYLASE REAGENT KIT2025-04-08
03701700800040 - ENVOY 500 AST REAGENT KIT2025-04-08
03701700800057 - ENVOY 500 URIC ACID REAG.KIT2025-04-08
03701700800064 - ENVOY 500 DIRECT BILIRUBIN REAGENT KIT2025-04-08
03701700800071 - ENVOY 500 TOTAL BILIRUBIN REAGENT KIT2025-04-08
03701700800088 - ENVOY 500 CALCIUM REAGENT KIT2025-04-08

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