MassARRAY Clean Resin 28g 8040

GUDID 00850010566054

AGENA BIOSCIENCE, INC.

Post-PCR cleanup kit IVD

• Primary Device ID: 00850010566054
• NIH Device Record Key: 3498d8c9-9982-468d-8ade-033fdf82ca30
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MassARRAY Clean Resin 28g
• Version Model Number: 8040
• Catalog Number: 8040
• Company DUNS: 079436896
• Company Name: AGENA BIOSCIENCE, INC.
• 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: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• 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

Customer Support Contacts

• Phone: +1(858)882-2725
• Email: glenn.wise@agenabio.com
• Phone: +1(858)882-2725
• Email: glenn.wise@agenabio.com
• Phone: +1(858)882-2725
• Email: glenn.wise@agenabio.com
• Phone: +1(858)882-2725
• Email: glenn.wise@agenabio.com
• Phone: +1(858)882-2725
• Email: glenn.wise@agenabio.com
• Phone: +1(858)882-2725
• Email: glenn.wise@agenabio.com
• Phone: +1(858)882-2725
• Email: glenn.wise@agenabio.com
• Phone: +1(858)882-2725
• Email: glenn.wise@agenabio.com
• Phone: +1(858)882-2725
• Email: glenn.wise@agenabio.com
• Phone: +1(858)882-2725
• Email: glenn.wise@agenabio.com
• Phone: +1(858)882-2725
• Email: glenn.wise@agenabio.com
• Phone: +1(858)882-2725
• Email: glenn.wise@agenabio.com
• Phone: +1(858)882-2725
• Email: glenn.wise@agenabio.com
• Phone: +1(858)882-2725
• Email: glenn.wise@agenabio.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850010566054 [Primary]

FDA Product Code

• DOP: MASS SPECTROMETER, CLINICAL USE

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: 2020-09-16
• Device Publish Date: 2020-09-08

Devices Manufactured by AGENA BIOSCIENCE, INC.

• 00850010566009 - MassARRAAY Dx: 2020-09-16
• 00850010566016 - CPM Dx: 2020-09-16
• 10850010566020 - SpectroChip CPM Kit (2x96): 2020-09-16
• 10850010566037 - SpectroChip CPM Kit (10x96): 2020-09-16
• 00850010566047 - SpectroChip Standalone Chip Only): 2020-09-16
• 00850010566054 - MassARRAY Clean Resin 28g: 2020-09-16
• 00850010566054 - MassARRAY Clean Resin 28g: 2020-09-16
• 10850010566068 - Calibrant: 2020-09-16