SEEKER® 2111

GUDID 05430003908716

The SEEKER® LSD Reagent Kit - IDUA|GAA|GBA|GLA is intended for quantitative measurement of the activity of alpha-L-iduronidase, alpha-D-glucosidase, beta-glucocerebrosidase and alpha-D-galactosidase A from newborn dried blood spot specimens, using the SEEKER Instrument as an aid in screening newborns for Mucopolysaccharidosis Type I, Pompe, Gaucher and Fabry diseases. Reduced activity of these enzymes may be indicative of these lysosomal storage diseases. The enzymes measured using the SEEKER LSD Reagent Kit- IDUA|GAA|GBA|GLA and their associated lysosomal storage diseases are listed: * alpha-L-iduronidase (IDUA) : Mucopolysaccharidosis Type I (MPS I) * alpha-D-glucosidase (GAA) : Pompe * beta-glucocerebrosidase (GBA) :Gaucher * alpha-D-galactosidase A (GLA) : Fabry

Lacar MDX Technologies

Newborn metabolic screen/congenital disorder IVD, reagent

• Primary Device ID: 05430003908716
• NIH Device Record Key: 7ce15145-44eb-4596-be82-34683bf0fa51
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SEEKER®
• Version Model Number: 2111
• Catalog Number: 2111
• 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: +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	05430003908716 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN150035

FDA Product Code

• PQT: Alpha-L-Iduronidase (Idua) Newborn Screening Test System

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 [SEEKER®]

• 05430003908990: SEEKER® LSD Reagent Kit - IDUA GAA
• 05430003908815: SEEKER® Personal Computer
• 05430003908761: SEEKER® Instrument
• 05430003908716: The SEEKER® LSD Reagent Kit - IDUA|GAA|GBA|GLA is intended for quantitative measurement of the
• 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