BAEBIES, INC.

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

Want to know more about this Organization? Request more information now!

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

Colorimeter, Photometer, Spectrophotometer For Clinical Use (JJQ) (3) General Purpose Reagent (PPM) (3) Multi-Analyte Controls, All Kinds (Assayed) (JJY) (2) Reagents, Specific, Analyte (MVU) (2)

Premarket Exempt

No Yes

Clear

Baebies - 00819704020210 Catalog Number : 3369

Device Description : Quality Control Dried Blood Spot - Intermediate

Device Class : 1

Duns Number: 079264306

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : Yes

Device Count : 1

SEEKER™ - 00819704020227 Catalog Number : 3416

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

Device Class : 1

Duns Number: 079264306

Premarket Exempt : No

Product Code : JJY

Prescription Use : Yes

Device Count : 1

SEEKER™ - 00819704020234 Catalog Number : 3132

Device Description : SEEKER™ Personal Computer

Device Class : 1

Duns Number: 079264306

Premarket Exempt : No

Product Code : JJQ

Prescription Use : Yes

Device Count : 1

SEEKER™ - 00819704020241 Catalog Number : 3145

Device Description : SEEKER™ Personal Computer

Device Class : 1

Duns Number: 079264306

Premarket Exempt : No

Product Code : JJQ

Prescription Use : Yes

Device Count : 1

SEEKER™ - 00819704020258 Catalog Number : 3428

Device Description : SEEKER™ Personal Computer

Device Class : 1

Duns Number: 079264306

Premarket Exempt : No

Product Code : JJQ

Prescription Use : Yes

Device Count : 1

Baebies 6-HMU GALC - 00819704020265 Catalog Number : 2103

Device Description : 6-HMU GALC Substrate.Analyte Specific Reagent - Analytical and performance chara 6-HMU GALC Substrate.Analyte Specific Reagent - Analytical and performance characteristics are not established.

Device Class :

Duns Number: 079264306

Premarket Exempt : Yes

Product Code : MVU

Prescription Use : Yes

Device Count : 1

Baebies Stop Solution - 00819704020272 Catalog Number : 3725

Device Description : Baebies Stop SolutionGeneral Purpose Reagent, For Laboratory Use.

Device Class : 1

Duns Number: 079264306

Premarket Exempt : Yes

Product Code : PPM

Prescription Use : Yes

Device Count : 1

Baebies 6-HMU Dilution Set - 00819704020289 Catalog Number : 2110

Device Description : 6-HMU Dilution SetGeneral Purpose Reagent, For Laboratory Use.

Device Class :

Duns Number: 079264306

Premarket Exempt : Yes

Product Code : PPM

Prescription Use : Yes

Device Count : 1

Baebies Extraction Solution - 00819704020296 Catalog Number : 3726

Device Description : Baebies Extraction SolutionGeneral Purpose Reagent, For Laboratory Use

Device Class : 1

Duns Number: 079264306

Premarket Exempt : Yes

Product Code : PPM

Prescription Use : Yes

Device Count : 1

Baebies 4-MU IDS - 00819704020302 Catalog Number : 3951

Device Description : 4-MU IDS Reagent Tube, 4.3mLAnalyte Specific Reagent - Analytical and performanc 4-MU IDS Reagent Tube, 4.3mLAnalyte Specific Reagent - Analytical and performance characteristics are not established.

Device Class : 1

Duns Number: 079264306

Premarket Exempt : Yes

Product Code : MVU

Prescription Use : Yes

Device Count : 1

Previous 1 2 3 4 Next