BAEBIES INC.

FDA Registration(s)#

GUDID Contact Samples#

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

• baebies.com

Registered Device Listings#

Product Codes Associated With Registrations#

PMN#

• FINDER G6PD

  2022-09-14

  Baebies, Inc.

GUDID#

• FINDER Instrument - 100-000054

  Baebies, Inc.

  2026-05-01

• FINDER Flu A&B/SARS-CoV-2 Test - 100-000068

  Baebies, Inc.

  2026-05-01

• FINDER Cleaning Accessory - 100-000061

  Baebies, Inc.

  2026-05-01

• FINDER RVP Buffer - 100-000076

  Baebies, Inc.

  2026-05-01

• FINDER Flu A&B/SARS-CoV-2 Positive Control Swab - 100-000077

  Baebies, Inc.

  2026-05-01

• FINDER Flu A&B/SARS-CoV-2 Negative Control Swab - 100-000078

  Baebies, Inc.

  2026-05-01

• Baebies Stop Solution - Baebies Stop SolutionGeneral Purpose Reagent, For Laboratory Use.

  Baebies, Inc.

  2018-12-12

• Baebies Extraction Solution - Baebies Extraction SolutionGeneral Purpose Reagent, For Laboratory Use

  Baebies, Inc.

  2018-12-12

• Baebies 4-MU IDS - 4-MU IDS Reagent Tube, 4.3mLAnalyte Specific Reagent - Analytical and performance characteristics are not established.

  Baebies, Inc.

  2018-10-04

• Baebies 4-MU Dilution Set - 4-MU Dilution SetGeneral Purpose Reagent, For Laboratory Use.

  Baebies, Inc.

  2018-10-04

• Baebies C-Stop Solution - Baebies C-Stop SolutionGeneral Purpose Reagent, For Laboratory Use.

  Baebies, Inc.

  2018-10-04

• FINDER - FINDER Instrument

  Baebies, Inc.

  2025-01-31

• FINDER - FINDER G6PD Test (Box of 16)

  Baebies, Inc.

  2025-01-31

• FINDER - FINDER G6PD TEST (Unit of Use)

  Baebies, Inc.

  2025-01-31

• FINDER - FINDER Pipette, 50µL (pack of 5 pipettes)

  Baebies, Inc.

  2025-01-31

• FINDER - FINDER Pipette, 50µL

  Baebies, Inc.

  2025-01-31

• SEEKER™ - SEEKER™ Filler Fluid

  Baebies, Inc.

  2017-09-19

• SEEKER™ - SEEKER™ Extraction Buffer

  Baebies, Inc.

  2017-09-19

• SEEKER™ - SEEKER™ disposable Cartridge

  Baebies, Inc.

  2017-09-19

• Baebies - Quality Control Dried Blood Spot - Base Pool

  Baebies, Inc.

  2018-01-18

• Baebies - Quality Control Dried Blood Spot - Low

  Baebies, Inc.

  2018-01-18

• Baebies - Quality Control Dried Blood Spot - Medium

  Baebies, Inc.

  2018-01-18

• Baebies - Quality Control Dried Blood Spot - High

  Baebies, Inc.

  2018-01-18

• SEEKER™ - SEEKER™ GAA Reagent (alpha-D-glucosidase)

  Baebies, Inc.

  2017-08-04

• SEEKER™ - SEEKER™ IDUA Reagent (alpha-L-iduronidase)

  Baebies, Inc.

  2017-08-04

• SEEKER™ - SEEKER™ GBA Reagent (ß-Glucocerebrosidase)

  Baebies, Inc.

  2017-08-04

• SEEKER™ - SEEKER™ GLA Reagent (alpha-D-galactosidase)

  Baebies, Inc.

  2017-08-04

• SEEKER™ - SEEKER™ Calibrant A

  Baebies, Inc.

  2017-08-04

• SEEKER™ - SEEKER™ Calibrant B

  Baebies, Inc.

  2017-08-04

• SEEKER™ - SEEKER™ Calibrant C

  Baebies, Inc.

  2017-08-04

• SEEKER™ - SEEKER™ Calibrant D

  Baebies, Inc.

  2017-08-04

• SEEKER™ - SEEKER™ Stop Buffer

  Baebies, Inc.

  2017-08-04

• 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

• SEEKER™ - SEEKER™ LSD Reagent Kit - IDUA GAA

  Baebies, Inc.

  2017-08-04

• SEEKER™ - The SEEKER™ Instrument is a quantitative in vitro diagnostic instrument for the determination of clinical chemistry analytes.

  Baebies, Inc.

  2017-08-04

• SEEKER™ - SEEKER™ Instrument & AccessoriesThe SEEKER™ Instrument is a quantitative in vitro diagnostic instrument for the determination of clinical chemistry analytes.

  Baebies, Inc.

  2017-08-04

• Baebies - Quality Control Dried Blood Spot - Intermediate

  Baebies, Inc.

  2018-01-18

• SEEKER™ - SEEKER™ Quality Control Dried Blood Spot KitContains 5 levels: QC Base Pool, QC Low, QC Intermediate, QC Medium, and QC High

  Baebies, Inc.

  2018-01-18

• SEEKER™ - SEEKER™ Personal Computer

  Baebies, Inc.

  2017-08-04

• SEEKER™ - SEEKER™ Personal Computer

  Baebies, Inc.

  2017-08-04

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