DEVICE: SEEKER™ (00819704020173)

Device Identifier (DI) Information

SEEKER™
2111
In Commercial Distribution
2111
BAEBIES, INC.
00819704020173
GS1

1
079264306 *Terms of Use
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
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Device Characteristics

Labeling does not contain MRI Safety Information
No
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?
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
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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
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
DEN150035 000
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between -80 and -70 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

fca27545-31b2-46ef-be53-2600b988d9d5
July 06, 2018
3
August 04, 2017
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
(844) 244-4034
techsupport@baebies.com
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