Vysis 07J22-012

GUDID 00884999027084

CEP 12 SpectrumOrange

ABBOTT MOLECULAR INC.

Chronic lymphocytic leukaemia (CLL) genetic mutation IVD, probe
Primary Device ID00884999027084
NIH Device Record Key9d51783c-ffa5-49d4-a158-a23796f42378
Commercial Distribution StatusIn Commercial Distribution
Brand NameVysis
Version Model Number07J22-012
Catalog Number07J22-012
Company DUNS878263359
Company NameABBOTT MOLECULAR 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

Customer Support Contacts

Phone+1(800)553-7042
Emailcustomerservice@abbottmolecular.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -20 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and -20 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100884999027084 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KIRCELLS, ANIMAL AND HUMAN, CULTURED

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-10

On-Brand Devices [Vysis]

00884999046634Vysis LSI NUP214 SpectrumOrange Probe
00884999046610Vysis LSI DEK SpectrumGreen Probe
00884999046085Vysis LSI FGFR2 (Tel) SpectrumGreen Probe
00884999046078Vysis LSI FGFR2 (Cen) SpectrumOrange Probe
00884999044722Vysis IntelliFISH Hybridization Buffer 5 x 250 uL
00884999044715Vysis IntelliFISH Hybridization Buffer 1 x 250 uL
00884999044234Vysis IntelliFISH Universal FFPE Tissue Pretreatment Protease (For 500 mL)
00884999044227Vysis IntelliFISH Universal FFPE Tissue Pretreatment Protease (For 50 mL)
00884999044210Vysis IntelliFISH Universal FFPE Tissue Pretreatment and Wash Reagents
00884999043664Vysis LSI CDKN2A SpectrumOrange Probe
00884999043312Vysis LSI PDGFRA SpectrumAqua Probe
00884999043305Vysis LSI 4q12 SpectrumGreen Probe
00884999043299Vysis LSI 4q12 SpectrumOrange Probe
00884999043282Vysis LSI ARSA SpectrumGreen Probe
00884999043275Vysis LSI HIRA SpectrumOrange Probe
00884999043268Vysis LSI PTEN SpectrumOrange Probe
00884999043251Vysis LSI SS18 (Cen) SpectrumGreen Probe
00884999043244Vysis LSI SS18 (Tel) SpectrumOrange Probe
00884999043237Vysis LSI MALT1 SpectrumOrange Probe
00884999043190Vysis LSI CDKN2C SpectrumGreen Probe
00884999042827Vysis LSI CKS1B SpectrumOrange Probe
00884999042780Vysis CLL FISH Probe Kit
00884999042773Vysis ALK Break Apart FISH Probe Kit
00884999042728Vysis ALK Break Apart FISH Probe Kit
00884999042636Vysis LSI ACTN4 SpectrumOrange Probe
00884999042629Vysis LSI 19p12 SpectrumGreen Probe
00884999042605Vysis LSI NTRK1 (Cen) SpectrumGreen Probe
00884999042599Vysis LSI NTRK1 (Tel) SpectrumRed Probe
00884999042575Vysis LSI FGFR2 SpectrumOrange Probe
00884999041615Vysis LSI FUS (Tel) SpectrumGreen Probe
00884999041585Vysis LSI BIRC3 SpectrumGreen Probe
00884999041578Vysis LSI RARA (Tel) SpectrumGreen Probe
00884999041561Vysis LSI RARA (Cen) SpectrumOrange Probe
00884999041554Vysis LSI PBX1 SpectrumOrange Probe
00884999041547Vysis LSI TCF3 SpectrumGreen Probe
00884999041530Vysis LSI ETV6 (Cen) SpectrumGreen Probe
00884999041523Vysis LSI ETV6 (Tel) SpectrumOrange Probe
00884999041516Vysis LSI FOXO1 (Cen) SpectrumGreen Probe
00884999041509Vysis LSI FOXO1 (Tel) SpectrumOrange Probe
00884999041493Vysis LSI DDIT3 (Tel) SpectrumGreen Probe
00884999041486Vysis LSI DDIT3 (Cen) SpectrumOrange Probe
00884999041479Vysis LSI FUS (Cen) SpectrumOrange Probe
00884999041462Vysis LSI CCND1 (Cen) SpectrumGreen Probe
00884999041455Vysis LSI CCND1 (Tel) SpectrumOrange Probe
00884999038424Vysis LSI STS SpectrumOrange Probe
00884999038165Vysis EGR1 FISH Probe Kit - SC (Specimen Characterization)
00884999038080Vysis LSI RET (Cen) SpectrumGreen Probe
00884999038073Vysis LSI RET (Tel) SpectrumOrange Probe
00884999038066Vysis LSI RET (Tel) SpectrumRed Probe
00884999038042Vysis LSI FGFR1 SpectrumRed Probe

Trademark Results [Vysis]

Mark Image

Registration | Serial
Company
Trademark
Application Date
VYSIS
VYSIS
86684397 5607387 Live/Registered
Abbott Molecular Inc.
2015-07-06
VYSIS
VYSIS
86684390 5607386 Live/Registered
Abbott Molecular Inc.
2015-07-06
VYSIS
VYSIS
74555181 2159170 Live/Registered
ABBOTT MOLECULAR INC.
1994-07-29
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