AccessGUDID - DEVICE: SEEKER™ (00819704020173)

GUDID

Device Identifier (DI) Information

Brand Name: SEEKER™
Version or Model: 2111
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2111
Company Name: BAEBIES, INC.

Primary DI Number: 00819704020173
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079264306 *Terms of Use

Device Description: The SEEKER™ LSD Reagent Kit - IDUA|GAA|GBA|GLA is intended for quantitative measurement of the activity of α-L-iduronidase, α-D-glucosidase, β-glucocerebrosidase and α-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. α-L-iduronidase (IDUA) - Mucopolysaccharidosis Type I (MPS I) α-D-glucosidase (GAA) - Pompe β-glucocerebrosidase (GBA) - Gaucher α-D-galactosidase (GLA) - Fabry

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:	Yes
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?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PQT	Alpha-L-Iduronidase (Idua) Newborn Screening Test System
PQU	Alpha-D-Glucosidase (Gaa) Newborn Screening Test System
PQV	ß-Glucocerebrosidase (Gba) Newborn Screening Test System
PQW	Alpha-D-Galactosidase A (Gla) Newborn Screening Test System
JIX	Calibrator, Multi-Analyte Mixture
PPM	General Purpose Reagent

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
DEN150035	000

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 -80 and -70 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: fca27545-31b2-46ef-be53-2600b988d9d5
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: August 04, 2017