AccessGUDID - DEVICE: NeoLSD MSMS kit (06438147356218)

GUDID

Device Identifier (DI) Information

Brand Name: NeoLSD MSMS kit
Version or Model: 3093-001U
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 3093-001U
Company Name: Wallac Oy

Primary DI Number: 06438147356218
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 540156544 *Terms of Use

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

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PQW	Alpha-D-Galactosidase A (Gla) Newborn Screening Test System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -30 and -16 Degrees Celsius
Storage Environment Temperature: between 2 and 8 Degrees Celsius
Storage Environment Temperature: between 2 and 25 Degrees Celsius
Storage Environment Temperature: between 2 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9d1db15b-2b28-4d7f-a251-8b7d77bba1f6
Public Version Date: July 06, 2023
Public Version Number: 3
DI Record Publish Date: November 28, 2018