LaCAR

GUDID 05430003908525

Quality Control Dried Blood Spot - Low

Lacar MDX Technologies

Newborn metabolic screen/congenital disorder IVD, control

• Primary Device ID: 05430003908525
• NIH Device Record Key: 4c54f4c2-5523-400d-9827-05ae72f382d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LaCAR
• Version Model Number: 0975
• 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: false
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +3202873944
• Email: customer@lacar-mdx.com
• Phone: +3202873944
• Email: customer@lacar-mdx.com
• Phone: +3202873944
• Email: customer@lacar-mdx.com
• Phone: +3202873944
• Email: customer@lacar-mdx.com
• Phone: +3202873944
• Email: customer@lacar-mdx.com
• Phone: +3202873944
• Email: customer@lacar-mdx.com
• Phone: +3202873944
• Email: customer@lacar-mdx.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -80 Degrees Celsius and -70 Degrees Celsius
• Storage Environment Temperature: Between -80 Degrees Celsius and -70 Degrees Celsius
• Storage Environment Temperature: Between -80 Degrees Celsius and -70 Degrees Celsius
• Storage Environment Temperature: Between -80 Degrees Celsius and -70 Degrees Celsius
• Storage Environment Temperature: Between -80 Degrees Celsius and -70 Degrees Celsius
• Storage Environment Temperature: Between -80 Degrees Celsius and -70 Degrees Celsius
• Storage Environment Temperature: Between -80 Degrees Celsius and -70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05430003908525 [Primary]

FDA Product Code

• JJY: Multi-Analyte Controls, All Kinds (Assayed)

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