CINtec PLUS Cytology 07478496001

GUDID 04015630977215

Ventana Medical Systems, Inc.

Ki67 antigen IVD, kit, enzyme immunohistochemistry
Primary Device ID04015630977215
NIH Device Record Key20aeac07-2b3c-409e-836a-ea5b639d7a27
Commercial Distribution StatusIn Commercial Distribution
Brand NameCINtec PLUS Cytology
Version Model Number100 test
Catalog Number07478496001
Company DUNS184042521
Company NameVentana Medical Systems, Inc.
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 Usetrue
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
GS104015630977215 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QKFImmunocytochemistry assay, p16/Ki-67

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-04-20
Device Publish Date2020-04-10

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