BAEBIES, INC.

BAEBIES, INC.

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

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Filters

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

Multi-Analyte Controls, All Kinds (Assayed) (JJY) (4) General Purpose Reagent (PPM) (3) Alpha-D-Glucosidase (Gaa) Newborn Screening Test System (PQU) (1) Alpha-L-Iduronidase (Idua) Newborn Screening Test System (PQT) (1) ß-Glucocerebrosidase (Gba) Newborn Screening Test System (PQV) (1)

Premarket Exempt

No Yes

Clear

SEEKER™ - 00819704020005 Catalog Number : 2573

Device Description : SEEKER™ Filler Fluid

Device Class :

Duns Number: 079264306

Premarket Exempt : No

Product Code : PPM

Prescription Use : Yes

Device Count : 1

SEEKER™ - 00819704020012 Catalog Number : 3140

Device Description : SEEKER™ Extraction Buffer

Device Class :

Duns Number: 079264306

Premarket Exempt : No

Product Code : PPM

Prescription Use : Yes

Device Count : 1

SEEKER™ - 00819704020029 Catalog Number : 3141

Device Description : SEEKER™ disposable Cartridge

Device Class :

Duns Number: 079264306

Premarket Exempt : No

Product Code : PPM

Prescription Use : Yes

Device Count : 1

Baebies - 00819704020036 Catalog Number : 0974

Device Description : Quality Control Dried Blood Spot - Base Pool

Device Class : 1

Duns Number: 079264306

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : Yes

Device Count : 1

Baebies - 00819704020043 Catalog Number : 0975

Device Description : Quality Control Dried Blood Spot - Low

Device Class : 1

Duns Number: 079264306

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : Yes

Device Count : 1

Baebies - 00819704020050 Catalog Number : 0976

Device Description : Quality Control Dried Blood Spot - Medium

Device Class : 1

Duns Number: 079264306

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : Yes

Device Count : 1

Baebies - 00819704020067 Catalog Number : 0977

Device Description : Quality Control Dried Blood Spot - High

Device Class : 1

Duns Number: 079264306

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : Yes

Device Count : 1

SEEKER™ - 00819704020081 Catalog Number : 1201

Device Description : SEEKER™ GAA Reagent (alpha-D-glucosidase)

Device Class : 2

Duns Number: 079264306

Premarket Exempt : No

Product Code : PQU

Prescription Use : Yes

Device Count : 1

SEEKER™ - 00819704020098 Catalog Number : 1200

Device Description : SEEKER™ IDUA Reagent (alpha-L-iduronidase)

Device Class : 2

Duns Number: 079264306

Premarket Exempt : No

Product Code : PQT

Prescription Use : Yes

Device Count : 1

SEEKER™ - 00819704020104 Catalog Number : 1203

Device Description : SEEKER™ GBA Reagent (ß-Glucocerebrosidase)

Device Class : 2

Duns Number: 079264306

Premarket Exempt : No

Product Code : PQV

Prescription Use : Yes

Device Count : 1

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