Alzheimer's Evalutation CSF Kit

GUDID 10860011770203

Alzheimer's Evalutation CSF Kit

Ditek Consulting, LLC

Phlebotomy kit
Primary Device ID10860011770203
NIH Device Record Key87cc30ff-7b37-40ea-a5ec-3266ae152412
Commercial Distribution StatusIn Commercial Distribution
Brand NameAlzheimer's Evalutation CSF Kit
Version Model Number140857
Company DUNS111296701
Company NameDitek Consulting, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS110860011770203 [Primary]

FDA Product Code

OIBBlood And Urine Collection Kit (Excludes Hiv Testing)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-09
Device Publish Date2025-05-01