NeoLSD MSMS kit

Basic Information

• Brand Name: NeoLSD MSMS kit
• Primary DI: 06438147356218
• Version / Model: 3093-001U
• Catalog Number: 3093-001U
• Company Name: Wallac Oy
• Labeler DUNS: 540156544
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-11-28
• Public Version: 3
• Public Version Date: 2023-07-06
• Public Version Status: Update
• Public Device Record Key: 9d1db15b-2b28-4d7f-a251-8b7d77bba1f6

Device Description

For the quantitative measurement of the activity of certain lysosomal enzymes in dried blood spots. Note: Kit contains multiple packages.

Device Characteristics

• Single Use: No
• 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: 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
PQW	Alpha-D-Galactosidase A (Gla) Newborn Screening Test System	Clinical Chemistry	862.1488	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60444	Newborn metabolic screen/congenital disorder IVD, kit, spectrophotometry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative screening of a clinical specimen for one or more congenital or metabolic disorders of the newborn, using a spectrophotometry method. It typically utilizes whole-blood neonate specimens dried on filter paper, and the analytes detected may include neonatal thyroxine (neonatal T4), neonatal thyroid stimulating hormone (neonatal TSH), 17-hydroxyprogesterone, immunoreactive trypsinogen, and various enzymes and/or amino acids, as indicators of congenital hypothyroidism, adrenal hyperplasia, cystic fibrosis, lysosomal storage disorders (LSDs), or other metabolic disorders.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06438147356218	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -30 – -16 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 2 – 25 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 2 – 30 Degrees Celsius