LATEX CONTROLS SI 305.100-A

GUDID 08056040141212

ALIFAX SRL

Erythrocyte sedimentation rate (ESR) IVD, control Erythrocyte sedimentation rate (ESR) IVD, control Erythrocyte sedimentation rate (ESR) IVD, control Erythrocyte sedimentation rate (ESR) IVD, control Erythrocyte sedimentation rate (ESR) IVD, control Erythrocyte sedimentation rate (ESR) IVD, control Erythrocyte sedimentation rate (ESR) IVD, control Erythrocyte sedimentation rate (ESR) IVD, control Erythrocyte sedimentation rate (ESR) IVD, control Erythrocyte sedimentation rate (ESR) IVD, control Erythrocyte sedimentation rate (ESR) IVD, control Erythrocyte sedimentation rate (ESR) IVD, control Erythrocyte sedimentation rate (ESR) IVD, control

• Primary Device ID: 08056040141212
• NIH Device Record Key: 6a2459dc-1f0f-4956-92cd-9c72400b1864
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LATEX CONTROLS
• Version Model Number: LATEX CONTROLS
• Catalog Number: SI 305.100-A
• 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 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08056040141212 [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

On-Brand Devices [LATEX CONTROLS]

• 08056040141229: LATEX CONTROLS
• 08056040141212: LATEX CONTROLS
• 08056040140031: LATEX CONTROLS
• 08056040140024: LATEX CONTROLS