Chromosome 17 DIG Probe ASR 06577164001

GUDID 04015630970858

Ventana Medical Systems, Inc.

Assay development analyte-specific reagent IVD
Primary Device ID04015630970858
NIH Device Record Keybd860cfc-936b-4d1d-b351-ef663bb46c4d
Commercial Distribution StatusIn Commercial Distribution
Brand NameChromosome 17 DIG Probe ASR
Version Model Number06577164001
Catalog Number06577164001
Company DUNS184042521
Company NameVentana Medical Systems, Inc.
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 Usefalse
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
GS104015630970858 [Primary]

FDA Product Code

MVUReagents, specific, analyte

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-11
Device Publish Date2021-02-03

Devices Manufactured by Ventana Medical Systems, Inc.

07613336149201 - VENTANA CLDN18 (43-14A) RxDx Assay2024-12-19
07613336223512 - anti-p40 (SP225) Rabbit Monoclonal Primary Antibody2024-05-29
07613336221099 - VENTANA FGFR2b (FPR2-D) Mouse Monoclonal Antibody2024-02-07
07613336219898 - anti-CD8 (SP239) Rabbit Monoclonal Primary Antibody2023-07-07
04015630967087 - CONFIRM anti-S100 (Polyclonal) Primary Antibody2022-12-15
04015630970063 - CONFIRM anti-ALK1 (ALK01) Primary Antibody2022-12-15
04015630970445 - CINtec® p16 Histology2022-12-15
04015630971015 - Anti-p53 (Bp53-11) Primary Antibody2022-12-15

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.