SEEKER™

Baebies, Inc. · Model 2111 · UDI-DI 00819704020173

510(k) clearances

Adverse events

Recalls

Facilities

Description

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 below. alpha-L-iduronidase (IDUA) - Mucopolysaccharidosis Type I (MPS I) alpha-D-glucosidase (GAA) - Pompe beta-glucocerebrosidase (GBA) - Gaucher alpha-D-galactosidase (GLA) - Fabry

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.