Smart Line TL Tube Luminometer 84007

GUDID B173840070

Smart Line TL Tube Luminometer is a stand-alone instrument with a built-in microprocessor software. Three softkeys and the key are all you need to operate the luminometer. Menus and parameters for functions that are not automated, are selected via these softkeys. The display shows the menu items, the actions performed and the user prompts. The luminometer includes an internal reading device for chip cards. Measurement protocols are saved on this chip card. During this procedure the user is prompted step by step to place the required tubes into the instrument for measurement. This ensures a high level of automation and standardization of the measurement process.

Spectral Medical Inc

Multiple clinical chemistry analyser IVD, laboratory, semi-automated

• Primary Device ID: B173840070
• NIH Device Record Key: ae8089b1-1d96-4820-9821-eaf603f88d71
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Smart Line TL Tube Luminometer
• Version Model Number: 84007
• Catalog Number: 84007
• Company DUNS: 248909939
• Company Name: Spectral Medical 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: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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: 18884264264
• Email: gguadagni@spectraldx.com
• Phone: 18884264264
• Email: gguadagni@spectraldx.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *0-40°C up to 75% humidity (@30°C), non-condensing
• Special Storage Condition, Specify: Between 0 and 0 *0-40°C up to 75% humidity (@30°C), non-condensing
• Special Storage Condition, Specify: Between 0 and 0 *0-40°C up to 75% humidity (@30°C), non-condensing
• Special Storage Condition, Specify: Between 0 and 0 *0-40°C up to 75% humidity (@30°C), non-condensing
• Special Storage Condition, Specify: Between 0 and 0 *0-40°C up to 75% humidity (@30°C), non-condensing
• Special Storage Condition, Specify: Between 0 and 0 *0-40°C up to 75% humidity (@30°C), non-condensing

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B173840070 [Primary]

FDA Product Code

• LXG: Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-12-23
• Device Publish Date: 2019-03-14

Devices Manufactured by Spectral Medical Inc

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