SEEKER™

Basic Information

• Brand Name: SEEKER™
• Primary DI: 00819704020081
• Version / Model: 1201
• Catalog Number: 1201
• Company Name: BAEBIES, INC.
• Labeler DUNS: 079264306
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-08-04
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 60bc6dc7-fc47-4fe9-9bcc-14a48d73039e

Device Description

SEEKER™ GAA Reagent (alpha-D-glucosidase)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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: No
• 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
PQU	Alpha-D-Glucosidase (Gaa) Newborn Screening Test System	Clinical Chemistry	862.1488	2

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	00819704020081	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
DEN150035	000

Storage Conditions

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