DEVICE: SEEKER™ (00819704020173)
Device Identifier (DI) Information
SEEKER™
2111
In Commercial Distribution
2111
BAEBIES, INC.
2111
In Commercial Distribution
2111
BAEBIES, INC.
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
Labeling does not contain MRI Safety Information | |
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No | |
Yes | |
Yes | |
No | |
Yes | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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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.
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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 [?] |
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DEN150035 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between -80 and -70 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
fca27545-31b2-46ef-be53-2600b988d9d5
July 06, 2018
3
August 04, 2017
July 06, 2018
3
August 04, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
(844) 244-4034
techsupport@baebies.com
techsupport@baebies.com