BAEBIES, INC.

Address:25 Alexandria Way,Durham,NC,27703,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Calibrator, Multi-Analyte Mixture (JIX) (6) General Purpose Reagent (PPM) (3) Alpha-D-Glucosidase (Gaa) Newborn Screening Test System (PQU) (2) Alpha-L-Iduronidase (Idua) Newborn Screening Test System (PQT) (2) Alpha-D-Galactosidase A (Gla) Newborn Screening Test System (PQW) (2) Fluorometer, For Clinical Use (KHO) (2) ß-Glucocerebrosidase (Gba) Newborn Screening Test System (PQV) (1)

Premarket Exempt

No Yes

Clear

SEEKER™ - 00819704020111 Catalog Number : 1202

Device Description : SEEKER™ GLA Reagent (alpha-D-galactosidase)

Device Class : 2

Duns Number: 079264306

Premarket Exempt : No

Product Code : PQW

Prescription Use : Yes

Device Count : 1

SEEKER™ - 00819704020128 Catalog Number : 2128

Device Description : SEEKER™ Calibrant A

Device Class : 2

Duns Number: 079264306

Premarket Exempt : No

Product Code : JIX

Prescription Use : Yes

Device Count : 1

SEEKER™ - 00819704020135 Catalog Number : 2129

Device Description : SEEKER™ Calibrant B

Device Class : 2

Duns Number: 079264306

Premarket Exempt : No

Product Code : JIX

Prescription Use : Yes

Device Count : 1

SEEKER™ - 00819704020142 Catalog Number : 2130

Device Description : SEEKER™ Calibrant C

Device Class : 2

Duns Number: 079264306

Premarket Exempt : No

Product Code : JIX

Prescription Use : Yes

Device Count : 1

SEEKER™ - 00819704020159 Catalog Number : 2131

Device Description : SEEKER™ Calibrant D

Device Class : 2

Duns Number: 079264306

Premarket Exempt : No

Product Code : JIX

Prescription Use : Yes

Device Count : 1

SEEKER™ - 00819704020166 Catalog Number : 1204

Device Description : SEEKER™ Stop Buffer

Device Class : 1

Duns Number: 079264306

Premarket Exempt : No

Product Code : PPM

Prescription Use : Yes

Device Count : 1

SEEKER™ - 00819704020173 Catalog Number : 2111

Device Description : The SEEKER™ LSD Reagent Kit - IDUA GAA GBA GLA is intended for quantitative meas 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) - Pompeβ-glucocerebrosidase (GBA) - Gaucherα-D-galactosidase (GLA) - Fabry

Device Class : 1

Duns Number: 079264306

Premarket Exempt : No

Product Code : PQT, PQU, PQV, PQW, JIX, PPM

Prescription Use : Yes

Device Count : 1

SEEKER™ - 00819704020180 Catalog Number : 2115

Device Description : SEEKER™ LSD Reagent Kit - IDUA GAA

Device Class : 1

Duns Number: 079264306

Premarket Exempt : No

Product Code : PQT, PQU, JIX, PPM

Prescription Use : Yes

Device Count : 1

SEEKER™ - 00819704020197 Catalog Number : 2188

Device Description : The SEEKER™ Instrument is a quantitative in vitro diagnostic instrument for the The SEEKER™ Instrument is a quantitative in vitro diagnostic instrument for the determination of clinical chemistry analytes.

Device Class : 1

Duns Number: 079264306

Premarket Exempt : No

Product Code : KHO

Prescription Use : Yes

Device Count : 1

SEEKER™ - 00819704020203 Catalog Number : 3154

Device Description : SEEKER™ Instrument & AccessoriesThe SEEKER™ Instrument is a quantitative in vitr SEEKER™ Instrument & AccessoriesThe SEEKER™ Instrument is a quantitative in vitro diagnostic instrument for the determination of clinical chemistry analytes.

Device Class : 1

Duns Number: 079264306

Premarket Exempt : No

Product Code : KHO

Prescription Use : Yes

Device Count : 1

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