SpectroChip Standalone Chip Only) 8608

GUDID 00850010566047

AGENA BIOSCIENCE, INC.

Mass spectrometry specimen target holder Mass spectrometry specimen target holder Mass spectrometry specimen target holder Mass spectrometry specimen target holder Mass spectrometry specimen target holder Mass spectrometry specimen target holder Mass spectrometry specimen target holder Mass spectrometry specimen target holder Mass spectrometry specimen target holder Mass spectrometry specimen target holder Mass spectrometry specimen target holder Mass spectrometry specimen target holder Mass spectrometry specimen target holder Mass spectrometry specimen target holder

• Primary Device ID: 00850010566047
• NIH Device Record Key: c18bc093-6227-4ccc-a4a5-c8516bfbbf25
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SpectroChip Standalone Chip Only)
• Version Model Number: 8608
• Catalog Number: 8608
• 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	00850010566047 [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
• 00850010566047 - SpectroChip Standalone Chip Only): 2020-09-16
• 00850010566054 - MassARRAY Clean Resin 28g: 2020-09-16
• 10850010566068 - Calibrant: 2020-09-16