LDL-Cholesterol Gen.3 07005717190

GUDID 04015630934584

Roche Diagnostics GmbH

Low density lipoprotein (LDL) cholesterol IVD, kit, enzyme spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, enzyme spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, enzyme spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, enzyme spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, enzyme spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, enzyme spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, enzyme spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, enzyme spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, enzyme spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, enzyme spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, enzyme spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, enzyme spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, enzyme spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, enzyme spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, enzyme spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, enzyme spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, enzyme spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, enzyme spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, enzyme spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, enzyme spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, enzyme spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, enzyme spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, enzyme spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, enzyme spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, enzyme spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, enzyme spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, enzyme spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, enzyme spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, enzyme spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, enzyme spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, enzyme spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, enzyme spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, enzyme spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, enzyme spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, enzyme spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, enzyme spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, enzyme spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, enzyme spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, enzyme spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, enzyme spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, spectrophotometry Low density lipoprotein (LDL) cholesterol IVD, kit, spectrophotometry
Primary Device ID04015630934584
NIH Device Record Key378de88f-d2b1-43bf-80a2-097d73e8c950
Commercial Distribution StatusIn Commercial Distribution
Brand NameLDL-Cholesterol Gen.3
Version Model Number7005717190
Catalog Number07005717190
Company DUNS315028860
Company NameRoche Diagnostics GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104015630934584 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LBRLDL & VLDL PRECIPITATION, HDL

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-16
Device Publish Date2021-02-08

On-Brand Devices [LDL-Cholesterol Gen.3]

0761333612137508057966190
040156309345917005768190
040156309345847005717190
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