SEEKER™

Basic Information

• Brand Name: SEEKER™
• Primary DI: 00819704020173
• Version / Model: 2111
• Catalog Number: 2111
• Company Name: Baebies, Inc.
• Labeler DUNS: 079264306
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-08-04
• Public Version: 6
• Public Version Date: 2026-04-08
• Public Version Status: Update
• Public Device Record Key: fca27545-31b2-46ef-be53-2600b988d9d5
• Distribution End Date: 2025-10-01

Device 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

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PQT	Alpha-L-Iduronidase (Idua) Newborn Screening Test System	Clinical Chemistry	862.1488	2
PQU	Alpha-D-Glucosidase (Gaa) Newborn Screening Test System	Clinical Chemistry	862.1488	2
PQV	ß-Glucocerebrosidase (Gba) Newborn Screening Test System	Clinical Chemistry	862.1488	2
PQW	Alpha-D-Galactosidase A (Gla) Newborn Screening Test System	Clinical Chemistry	862.1488	2
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	862.1150	2
PPM	General Purpose Reagent	Pathology	864.4010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
60442	Newborn metabolic screen/congenital disorder IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay intended to be used in screening a clinical specimen for one or more congenital or metabolic disorders of the newborn. The test typically utilizes whole blood neonate specimens dried on filter paper, and the range of analytes detected may include neonatal thyroxine (neonatal T4), neonatal thyroid stimulating hormone (neonatal TSH), 17-hydroxyprogesterone, immunoreactive trypsinogen, various enzymes and/or amino acids, as indicators of congenital hypothyroidism, adrenal hyperplasia, cystic fibrosis, or other metabolic disorders.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00819704020173	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -80 – -70 Degrees Celsius