Excel® Chemistry Analyzer (Spanish) G7700S-001

GUDID 00657498000397

This instrument is intended to be used to read and calculate the results of in-vitro clinical diagnostic assays, as well as any other application requiring absorbance or concentration readings at or near the available wavelengths. This general purpose instrument is intended to be used by laboratory professionals capable of selecting the appropriate features and options for each specific clinical application.

STANBIO LABORATORY, L.P.

Multiple clinical chemistry analyser IVD, laboratory, semi-automated

• Primary Device ID: 00657498000397
• NIH Device Record Key: 646bda04-f8ac-43b5-a1b1-038c3a3dee4c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Excel® Chemistry Analyzer (Spanish)
• Version Model Number: G7700S-001
• Catalog Number: G7700S-001
• Company DUNS: 045361136
• Company Name: STANBIO LABORATORY, L.P.
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 18005315535
• Email: stanbiolab@ekfdiagnostics.com
• Phone: 18005315535
• Email: stanbiolab@ekfdiagnostics.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00657498000397 [Primary]

FDA Product Code

• JJQ: Colorimeter, Photometer, Spectrophotometer For Clinical 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: 2018-04-17

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