rapid ID 32 STREP

GUDID 03573026066536

rapid ID 32 STREP is a standardized system for the identification of streptococci and enterococci, and those most common related organisms, in 4 hours

BIOMERIEUX SA

Multiple Streptococcus bacterial species culture isolate identification IVD, kit Multiple Streptococcus bacterial species culture isolate identification IVD, kit Multiple Streptococcus bacterial species culture isolate identification IVD, kit Multiple Streptococcus bacterial species culture isolate identification IVD, kit Multiple Streptococcus bacterial species culture isolate identification IVD, kit Multiple Streptococcus bacterial species culture isolate identification IVD, kit Multiple Streptococcus bacterial species culture isolate identification IVD, kit Multiple Streptococcus bacterial species culture isolate identification IVD, kit Multiple Streptococcus bacterial species culture isolate identification IVD, kit Multiple Streptococcus bacterial species culture isolate identification IVD, kit Multiple Streptococcus bacterial species culture isolate identification IVD, kit Multiple Streptococcus bacterial species culture isolate identification IVD, kit Multiple Streptococcus bacterial species culture isolate identification IVD, kit Multiple Streptococcus bacterial species culture isolate identification IVD, kit Multiple Streptococcus bacterial species culture isolate identification IVD, kit

• Primary Device ID: 03573026066536
• NIH Device Record Key: ab90cb75-9745-4cb3-9329-c42681f9fb63
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: rapid ID 32 STREP
• Version Model Number: rapid ID 32 STREP
• Company DUNS: 276816717
• Company Name: BIOMERIEUX SA
• 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: 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

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 8 Degrees Celsius
• 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 8 Degrees Celsius
• 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 8 Degrees Celsius
• 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 8 Degrees Celsius
• 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 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	03573026066536 [Package]; Contains: 03573026588625; Package: [25 Units]; In Commercial Distribution
GS1	03573026588625 [Primary]

FDA Product Code

• JTO: DISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-04-20
• Device Publish Date: 2020-04-10

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