Endotoxin Activity Assay (EAA) EAAST-NA

GUDID B173EAASTNA0

The EAA™ is a rapid in vitro diagnostic test that utilizes a specific monoclonal antibody to measure the endotoxin activity in EDTA whole blood specim

Spectral Medical Inc

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• Primary Device ID: B173EAASTNA0
• NIH Device Record Key: db09d7c1-38de-4d08-bb1b-cfe3d167c11d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Endotoxin Activity Assay (EAA)
• Version Model Number: EAAST-NA
• Catalog Number: EAAST-NA
• Company DUNS: 248909939
• Company Name: Spectral Medical 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8884264264
• Email: gguadagni@spectraldx.com
• Phone: 8884264264
• Email: gguadagni@spectraldx.com
• Phone: 18884264264
• Email: shung@spectraldx.com
• Phone: 18884264264
• Email: shung@spectraldx.com
• Phone: 18884264264
• Email: shung@spectraldx.com
• Phone: 18884264264
• Email: shung@spectraldx.com
• Phone: 18884264264
• Email: shung@spectraldx.com
• Phone: 18884264264
• Email: shung@spectraldx.com
• Phone: 18884264264
• Email: shung@spectraldx.com
• Phone: 18884264264
• Email: shung@spectraldx.com
• Phone: 18884264264
• Email: shung@spectraldx.com
• Phone: 18884264264
• Email: shung@spectraldx.com
• Phone: 18884264264
• Email: shung@spectraldx.com
• Phone: 18884264264
• Email: shung@spectraldx.com
• Phone: 18884264264
• Email: shung@spectraldx.com
• Phone: 18884264264
• Email: shung@spectraldx.com
• Phone: 18884264264
• Email: shung@spectraldx.com
• Phone: 18884264264
• Email: shung@spectraldx.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B173EAASTNA0 [Primary]

FDA Product Code

• NGS: Assay, Endotoxin Activity, Chemiluminescent

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-03-15
• Device Publish Date: 2018-01-09

On-Brand Devices [Endotoxin Activity Assay (EAA)]

• B173EAASTNA0: The EAA™ is a rapid in vitro diagnostic test that utilizes a specific monoclonal antibody to m
• B173EAAST200: The EAA™ is a rapid in vitro diagnostic test that utilizes a specific monoclonal antibody to m