RaPET® s-LE 1160-050

GUDID 00657498001288

Latex Agglutination Slide Test for the Detection and Quantitation of serum antinucleoprotein factors associated with systemic Lupus Erythematosis in Human Serum.

STANBIO LABORATORY, L.P.

Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, reagent

• Primary Device ID: 00657498001288
• NIH Device Record Key: f40aa357-0d8b-4b3e-b03b-b75075660706
• Commercial Distribution Discontinuation: 2019-02-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: RaPET® s-LE
• Version Model Number: 1160-050
• Catalog Number: 1160-050
• 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	00657498001288 [Primary]

FDA Product Code

• LJM: Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls

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: 2019-02-04
• Device Publish Date: 2016-09-24

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• 00657498001806 - Standard 1: 2020-03-02 To provide calibration points for the Sodium, Potassium, and Chloride electrodes on the ISE module of Roche Cobas® Chemistry Sy