MetaSystems Probes D-5114-999-OG

GUDID 04251315809307

XL t(8;21) plus, 10x 100µl, Translocation/Dual Fusion Probe

MetaSystems Probes GmbH

Assay development analyte-specific reagent IVD

• Primary Device ID: 04251315809307
• NIH Device Record Key: 32663dc4-60f2-48e3-a20a-2ee12f69e14e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MetaSystems Probes
• Version Model Number: D-5114-999-OG
• Catalog Number: D-5114-999-OG
• Company DUNS: 313215719
• Company Name: MetaSystems Probes GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04251315809307 [Primary]

FDA Product Code

• MVU: Reagents, Specific, Analyte

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-11-23
• Device Publish Date: 2022-11-15

On-Brand Devices [MetaSystems Probes]

• 04251315820982: XCE 11 orange, Centromere Specific Probe
• 04251315820951: XCE 10 green, Centromere-Specific Probe
• 04251315819818: XCP 4 orange, Whole Chromosme Paint
• 04251315819795: XCP 4 green, Whole Chromosome Paint
• 04251315819764: XCP 3 orange, Whole Chromsome Paint
• 04251315819740: XCP 3 green, Whole Chromosome Paint
• 04251315819726: XCP 2 orange, Whole Chromosome Paint
• 04251315819702: XCP 2 green, Whole Chromosome Paint
• 04251315819689: XCP 1 orange, Whole Chromosome Paint
• 04251315819665: XCP 1 green, Whole Chromosome Paint
• 04251315818989: 24XCyte, Human MultiColor FISH, 10x60µl
• 04251315818972: 24XCyte, Human Multicolor FISH, 2x60µl
• 04251315818965: 24XCyte, Human Multicolor FISH, 60µl
• 04251315818125: XL 7q22/7q36, Deletion Probe
• 04251315818118: XL 5q31/5q33, Deletion Probe
• 04251315818101: XL FGFR1, Break Apart
• 04251315818095: XL 6q21/6q23, Deletion Probe
• 04251315818088: XL TET2, Deletion probe
• 04251315808768: XL TET2, 10x 100µl, Deletion Probe
• 04251315807358: XL 5q31/5q33, 10x100µl, Deletion Probe
• 04251315807303: XL 7q22/7q36, 10x 100µl, Deletion Probe
• 04251315807099: XL FGFR1, 10x 100µl, Break Apart
• 04251315806924: XL 6q21/6q23, 10x 100µl, Deletion Probe
• 04251315818194: XL DLEU/LAMP, Deletion Probe
• 04251315818187: XL CDKN2A, Deletion Probe
• 04251315818170: XL BCR/ABL1 plus, Dual Fusion Probe
• 04251315818163: XL Iso(17q), Deletion Probe
• 04251315818156: XL MDM2, Amplification Probe
• 04251315818149: XL ATM/TP53, Deletion Probe
• 04251315808485: XL CDKN2A, 10x 100µl, Deletion Probe
• 04251315807426: XL MDM2, 10x100µl, Amplification Probe
• 04251315806931: XL ATM/TP53, 10x 100µl, Deletion Probe
• 04251315805323: XL BCR/ABL1 plus, 10x 100µl, Dual Fusion Probe
• 04251315820586: XCP X green, Whole Chromosme Paint, 2x 50µl
• 04251315819757: XCP 3 green, Whole Chromosme Paint, 2x 50µl
• 04251315819733: XCP 2 orange, Whole Chromosme Paint, 2x 50µl
• 04251315819719: XCP 2 green, Whole Chromosme Paint, 2x 50µl
• 04251315819696: XCP 1 orange, Whole Chromosme Paint, 2x 50µl
• 04251315819672: XCP 1 green, Whole Chromosome Paint, 2x 50µl
• 04251315811201: XCE 11 green, 10x 50µl, Centromere-Specific Probe
• 04251315810174: XCE 10 red, 4x conc., 125µl, Centromere-Specific Probe
• 04251315810150: XCE 3 blue, 4x conc., 125µl, Centromere-Specific Probe
• 04251315808393: XCE 3 orange, 4x conc., 125µl, Centromere-Specific Probe
• 04251315808386: XCE 17 blue, 4x conc., 125µl, Centromere-Specific Probe
• 04251315807440: XCE 12 blue, 10x 50µl, Centromere-Specific Probe
• 04251315807419: XCE 12 green, 10x 50µl, Centromere-Specific Probe
• 04251315820067: XCP 10 orange, Whole Chromosme Paint, 2x 50µl
• 04251315820050: XCP 10 orange, Whole Chromosme Paint, 50µl
• 04251315820043: XCP 10 green, Whole Chromosme Paint, 2x 50µl
• 04251315820036: XCP 10 green, Whole Chromosme Paint, 50µl