Glycated Serum Protein Linearity Set 2380-201

GUDID 00657498001134

Stanbio Glycated Serum Protein (GSP) Linearity Set is intended to be used for quality control procedures in verifying the linearity throughout the reportable range of Stanbio’s Glycated Serum Protein (GSP) LiquiColor®. For in-vitro diagnostic use only.

STANBIO LABORATORY, L.P.

Fructosamine IVD, control Fructosamine IVD, control

• Primary Device ID: 00657498001134
• NIH Device Record Key: 9c8138e4-7a40-443d-b1ae-f7b39e0c3d25
• Commercial Distribution Discontinuation: 2019-04-05
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Glycated Serum Protein Linearity Set
• Version Model Number: 2380-201
• Catalog Number: 2380-201
• 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: 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: 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 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00657498001134 [Primary]

FDA Product Code

• JJX: Single (Specified) Analyte Controls (Assayed And Unassayed)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-04-08
• Device Publish Date: 2016-09-24

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