Calibrant 00436

GUDID 10850010566068

AGENA BIOSCIENCE, INC.

Complement components C3/C3c IVD, calibrator

• Primary Device ID: 10850010566068
• NIH Device Record Key: a7c0000f-84b5-4f28-b403-0953759fb2c7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Calibrant
• Version Model Number: 00436
• Catalog Number: 00436
• Company DUNS: 079436896
• Company Name: AGENA BIOSCIENCE, INC.
• Device Count: 5
• 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	00850010566061 [Primary]
GS1	10850010566068 [Unit of Use]

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
• 10850010566068 - Calibrant: 2020-09-16
• 10850010566068 - Calibrant: 2020-09-16