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Seeker™

FDA UDI

Class II (US FDA UDI)

by Baebies Inc.

Identity

Trade Name
SEEKER™ FDA UDI
Generic Name
Newborn metabolic screen/congenital disorder IVD, reagent FDA UDI
Device Name
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 FDA UDI
Model / Reference
2111 FDA UDI
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 FDA UDI

Identifiers

Catalog Number
2111 FDA UDI
Primary DI / UDI-DI
00819704020173 FDA UDI
510(k) Number
DEN150035 FDA UDI
FDA Product Code
PQT FDA UDI
PQU FDA UDI
PQV FDA UDI
PQW FDA UDI
JIX FDA UDI
PPM FDA UDI
GMDN Term
Newborn metabolic screen/congenital disorder IVD, reagent FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1488 FDA UDI
862.1150 FDA UDI
864.4010 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Newborn metabolic screen/congenital disorder IVD, reagent

Seeker™ by Baebies Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Newborn metabolic screen/congenital disorder IVD, reagent.

Cleared under the same submission

DEN150035 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Baebies Inc.

Sources (1)

  • FDA UDI fca27545-31b2-46ef-be53-2600b988d9d5 37 fields · synced May 30, 2026