LaCAR 3953

GUDID 05430003908730

C-Stop Solution General Purpose Reagent, For Laboratory Use.

Lacar MDX Technologies

Newborn metabolic screen/congenital disorder IVD, reagent

• Primary Device ID: 05430003908730
• NIH Device Record Key: 698ef31e-9883-4dc7-8714-3d7db75a2f67
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LaCAR
• Version Model Number: 3673
• Catalog Number: 3953
• Company DUNS: 371365041
• Company Name: Lacar MDX Technologies
• 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: true
• 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

Customer Support Contacts

• Phone: +32042873944
• Email: customer@lacar-mdx.com
• Phone: +32042873944
• Email: customer@lacar-mdx.com
• Phone: +32042873944
• Email: customer@lacar-mdx.com
• Phone: +32042873944
• Email: customer@lacar-mdx.com
• Phone: +32042873944
• Email: customer@lacar-mdx.com
• Phone: +32042873944
• Email: customer@lacar-mdx.com
• Phone: +32042873944
• Email: customer@lacar-mdx.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05430003908723 [Primary]
GS1	05430003908730 [Package]; Contains: 05430003908723; Package: Box [12 Units]; In Commercial Distribution

FDA Product Code

• PPM: General Purpose Reagent

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: 2026-01-23
• Device Publish Date: 2026-01-15

On-Brand Devices [LaCAR]

• 05430003908860: Extraction Solution General Purpose Reagent, For Laboratory Use
• 05430003908846: 6-HMU Dilution Set General Purpose Reagent, For Laboratory Use.
• 05430003908808: Stop Solution General Purpose Reagent, For Laboratory Use.
• 05430003908785: 4-MU Dilution Set General Purpose Reagent, For Laboratory Use.
• 05430003908730: C-Stop Solution General Purpose Reagent, For Laboratory Use.
• 05430003908556: Quality Control Dried Blood Spot - Intermediate
• 05430003908549: Quality Control Dried Blood Spot - High
• 05430003908532: Quality Control Dried Blood Spot - Medium
• 05430003908525: Quality Control Dried Blood Spot - Low
• 05430003908518: Quality Control Dried Blood Spot - Base Pool