SEEKER® 2130

GUDID 05430003908662

SEEKER® Calibrant C

Lacar MDX Technologies

Newborn metabolic screen/congenital disorder IVD, calibrator

• Primary Device ID: 05430003908662
• NIH Device Record Key: 56685887-76db-48a8-81d4-9916d0804085
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SEEKER®
• Version Model Number: 2130
• Catalog Number: 2130
• Company DUNS: 371365041
• Company Name: Lacar MDX Technologies
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: false
• 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 -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	05430003908662 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN150035

FDA Product Code

• JIX: Calibrator, Multi-Analyte Mixture

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

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• 05430003908815: SEEKER® Personal Computer
• 05430003908761: SEEKER® Instrument
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• 05430003908709: SEEKER® Filler Fluid
• 05430003908679: SEEKER® Calibrant D
• 05430003908662: SEEKER® Calibrant C
• 05430003908655: SEEKER® Calibrant B
• 05430003908648: SEEKER® Calibrant A
• 05430003908631: SEEKER® Stop Buffer
• 05430003908624: SEEKER® GBA Reagent (ß-Glucocerebrosidase)
• 05430003908617: SEEKER® GLA Reagent (alpha-D-galactosidase)
• 05430003908600: SEEKER® GAA Reagent (alpha-D-glucosidase)
• 05430003908594: SEEKER® IDUA Reagent (alpha-L-iduronidase)
• 05430003908693: SEEKER® Extraction Buffer
• 05430003908563: SEEKER® Quality Control Dried Blood Spot Kit Contains 5 levels: QC Base Pool, QC Low, QC Interm
• 05430003908471: SEEKER® Cartridge