FDA.reportPublic FDA data

BAEBIES INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30112409823011240982BAEBIES INC.1N2026-01-0125 Alexandria Way Durham NC US 27703

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00819704020074FINDER Instrument - 100-00005419194203329findsupport@baebies.com
00819704020265Baebies 6-HMU GALC - 6-HMU GALC Substrate.Analyte Specific Reagent - Analytical and performance characteristics are not established.844-244-4034techsupport@baebies.com
00819704020289Baebies 6-HMU Dilution Set - 6-HMU Dilution SetGeneral Purpose Reagent, For Laboratory Use.844-244-4034techsupport@baebies.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1851691824618074K252269FINDER Flu A&B/SARS-CoV-2 TestQOF2026-03-30
1851691671574382K201049FINDER G6PDJBF2022-09-14
1851691972866111DEN150035SEEKER SystemPQW2017-02-03
1851691189365341
1851691313124436
1851691412476124
1851691517883744
1851691656149716
1851691217017106
1851691640485096
1851691803920729
1851691972866111

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
QOF12026-03-30
JBF12022-09-14
PQW12017-02-03

PMN#

GUDID#

SEEKER™ - The SEEKER LSD Reagent Kit - IDUA GAA GBA GLA is intended for quantitative measurement of the activity of alpha-L-iduronidase, alpha-D-glucosidase, beta-glucocerebrosidase and alpha-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.alpha-L-iduronidase (IDUA) - Mucopolysaccharidosis Type I (MPS I)alpha-D-glucosidase (GAA) - Pompebeta-glucocerebrosidase (GBA) - Gaucheralpha-D-galactosidase (GLA) - Fabry

Baebies, Inc.

2017-08-04

48 records. Showing 1-40. Next