TEST1 THL SI 195.210/THL

GUDID 08056040141519

TEST-1 THL - ESR automated analyzer, with Software for Latex Controls. Using different CBC rack metal adaptors.

ALIFAX SRL

Erthrocyte sedimentation rate (ESR) analyser IVD Erthrocyte sedimentation rate (ESR) analyser IVD Erthrocyte sedimentation rate (ESR) analyser IVD Erthrocyte sedimentation rate (ESR) analyser IVD Erthrocyte sedimentation rate (ESR) analyser IVD Erthrocyte sedimentation rate (ESR) analyser IVD Erthrocyte sedimentation rate (ESR) analyser IVD Erthrocyte sedimentation rate (ESR) analyser IVD Erthrocyte sedimentation rate (ESR) analyser IVD Erthrocyte sedimentation rate (ESR) analyser IVD Erthrocyte sedimentation rate (ESR) analyser IVD Erthrocyte sedimentation rate (ESR) analyser IVD Erthrocyte sedimentation rate (ESR) analyser IVD

• Primary Device ID: 08056040141519
• NIH Device Record Key: b96403c3-cfa1-414f-b73d-72f6e95e38be
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TEST1 THL
• Version Model Number: TEST1 THL
• Catalog Number: SI 195.210/THL
• 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 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 65 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08056040141519 [Primary]

FDA Product Code

• GKB: Device, Automated Sedimentation Rate

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