Vysis 05J39-005

GUDID 00884999011731

ProbeChek Normal Male Amniocyte Control Slides

ABBOTT MOLECULAR INC.

Multiple congenital aneuploidy screening IVD, control

• Primary Device ID: 00884999011731
• NIH Device Record Key: 85eb08bd-be6a-411f-a0fb-c36e24636363
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vysis
• Version Model Number: 05J39-005
• Catalog Number: 05J39-005
• Company DUNS: 878263359
• Company Name: ABBOTT MOLECULAR INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)553-7042
• Email: customerservice@abbottmolecular.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *The probeChek Control Slides should be stored in a sealed container with desiccant to protect from humidity
• Special Storage Condition, Specify: Between 0 and 0 *The probeChek Control Slides should be stored in a sealed container with desiccant to protect from humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884999011731 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K010288

FDA Product Code

• OYU: Dna-probe kit, human chromosome

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-01

On-Brand Devices [Vysis]

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