HB&L UROQUATTRO LIGHT SI 190.300L

GUDID 08056040141502

ALIFAX SRL

Urine analyser IVD, laboratory

• Primary Device ID: 08056040141502
• NIH Device Record Key: 20c18b3d-72f2-4feb-a97f-434e3c1a6933
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HB&L UROQUATTRO LIGHT
• Version Model Number: HB&L UROQUATTRO LIGHT
• Catalog Number: SI 190.300L
• 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: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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 -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08056040141502 [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