DIAGNOSTIC HYBRIDS, INC.

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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

FORMULATIONS, BALANCED SALT SOLUTIONS (KIP) (8) MEDIA AND COMPONENTS, SYNTHETIC CELL AND TISSUE CULTURE (KIT) (2)

Premarket Exempt

Yes No

Clear

DHI Media & Controls - 30014613330998 Catalog Number : 03-05300

Device Description : C. DIFFICILE ANTI-TOXIN REAGENT

Device Class : 1

Duns Number: 117359612

Premarket Exempt : Yes

Product Code : KIP

Prescription Use : Yes

Device Count : 1

Ready Cells - 30014613331001 Catalog Number : 05-360075

Device Description : RC RMIX RINSE BUFFER

Device Class : 1

Duns Number: 117359612

Premarket Exempt : Yes

Product Code : KIT

Prescription Use : Yes

Device Count : 1

Ready Cells - 30014613331018 Catalog Number : 05-370100

Device Description : RC RMIX REFEED MEDIUM

Device Class : 1

Duns Number: 117359612

Premarket Exempt : Yes

Product Code : KIT

Prescription Use : Yes

Device Count : 1

DHI Media & Controls - 30014613331025 Catalog Number : 10-010100

Device Description : PEN/STREP 10K/10K

Device Class : 1

Duns Number: 117359612

Premarket Exempt : Yes

Product Code : KIP

Prescription Use : Yes

Device Count : 1

DHI Media & Controls - 30014613331032 Catalog Number : 10-020100

Device Description : AMPHOTERICIN B, 250 UG/ML

Device Class : 1

Duns Number: 117359612

Premarket Exempt : Yes

Product Code : KIP

Prescription Use : Yes

Device Count : 1

DHI Media & Controls - 30014613331049 Catalog Number : 10-030010

Device Description : GENTAMICIN 50 MG/ML

Device Class : 1

Duns Number: 117359612

Premarket Exempt : Yes

Product Code : KIP

Prescription Use : Yes

Device Count : 1

DHI Media & Controls - 30014613331056 Catalog Number : 10-040003

Device Description : ANTIBIOTIC SOLUTION

Device Class : 1

Duns Number: 117359612

Premarket Exempt : Yes

Product Code : KIP

Prescription Use : Yes

Device Count : 1

DHI Media & Controls - 30014613331063 Catalog Number : 10-080100

Device Description : HBSS DILUENT

Device Class : 1

Duns Number: 117359612

Premarket Exempt : Yes

Product Code : KIP

Prescription Use : Yes

Device Count : 1

DHI Media & Controls - 30014613331070 Catalog Number : 10-080500

Device Description : HBSS DILUENT

Device Class : 1

Duns Number: 117359612

Premarket Exempt : Yes

Product Code : KIP

Prescription Use : Yes

Device Count : 1

DHI Media & Controls - 30014613331087 Catalog Number : 10-090100

Device Description : PBS 10X

Device Class : 1

Duns Number: 117359612

Premarket Exempt : Yes

Product Code : KIP

Prescription Use : Yes

Device Count : 1

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