RAA BACTERIAL REAGENT PACK SI 190.902

GUDID 08056040142615

ALIFAX SRL

Antimicrobial activity testing agar culture medium IVD Antimicrobial activity testing agar culture medium IVD Antimicrobial activity testing agar culture medium IVD Antimicrobial activity testing agar culture medium IVD Antimicrobial activity testing agar culture medium IVD Antimicrobial activity testing agar culture medium IVD Antimicrobial activity testing agar culture medium IVD Antimicrobial activity testing agar culture medium IVD Antimicrobial activity testing agar culture medium IVD Antimicrobial activity testing agar culture medium IVD Antimicrobial activity testing agar culture medium IVD Antimicrobial activity testing agar culture medium IVD Antimicrobial activity testing agar culture medium IVD

• Primary Device ID: 08056040142615
• NIH Device Record Key: 9058c90b-8c19-4e03-8119-0c6515d31981
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RAA BACTERIAL REAGENT PACK
• Version Model Number: RAA BACTERIAL REAGENT PACK
• Catalog Number: SI 190.902
• Company DUNS: 435930630
• Company Name: ALIFAX SRL
• 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: 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08056040142615 [Primary]

FDA Product Code

• JTA: Monitor, Microbial Growth

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: 2022-10-14
• Device Publish Date: 2022-10-06

Devices Manufactured by ALIFAX SRL

• 08056040148778 - LIGHT SCATTERING TEST KIT: 2022-10-28
• 08056040148945 - TEST1 2.0: 2022-10-21
• 08056040140024 - LATEX CONTROLS: 2022-10-14
• 08056040140031 - LATEX CONTROLS: 2022-10-14
• 08056040140048 - LATEX CALIBRATORS: 2022-10-14
• 08056040140086 - URO-QUICK SCREENING KIT: 2022-10-14
• 08056040140291 - ALFRED 60: 2022-10-14
• 08056040140307 - HB&L UROQUATTRO: 2022-10-14