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

RESPIRATORY SYNCYTIAL VIRUS, ANTIGEN, ANTIBODY, IFA (LKT) (6) FORMULATIONS, BALANCED SALT SOLUTIONS (KIP) (3) ANTISERA, FLUORESCENT, ADENOVIRUS 1-33 (GNY) (1) ANTIGENS, CF (INCLUDING CF CONTROL), PARAINFLUENZA VIRUS 1-4 (GQS) (1) Antisera, fluorescent, human metapneumovirus (OMG) (1) ANTISERA, HAI, INFLUENZA VIRUS A, B, C (GNS) (1) ANTISERA, CF, INFLUENZA VIRUS A, B, C (GNW) (1)

Premarket Exempt

Yes No

Clear

D3 Fastpoint - 30014613330875 Catalog Number : 01-123504

Device Description : L-DFA Parainfluenza Virus/Adenovirus Reagent

Device Class : 1

Duns Number: 117359612

Premarket Exempt : No

Product Code : GNY, OMG, GQS, LKT, GNS

Prescription Use : Yes

Device Count : 1

D3 Duet - 30014613330882 Catalog Number : 01-200000

Device Description : D3 Duet DFA Influenza A/Respiratory Virus Screening kit

Device Class : 1

Duns Number: 117359612

Premarket Exempt : No

Product Code : GNW

Prescription Use : Yes

Device Count : 1

D3 Duet - 30014613330899 Catalog Number : 01-205010

Device Description : D3 Duet DFA Influenza A Screening reagent

Device Class : 1

Duns Number: 117359612

Premarket Exempt : No

Product Code : LKT

Prescription Use : Yes

Device Count : 1

D3 Duet - 30014613330905 Catalog Number : 01-210000

Device Description : D3 Duet DFA RSV/Respiratory Virus Screening Kit

Device Class : 1

Duns Number: 117359612

Premarket Exempt : No

Product Code : LKT

Prescription Use : Yes

Device Count : 1

D3 Duet - 30014613330912 Catalog Number : 01-215002

Device Description : D3 Duet DFA RSV Screening Reagent 2ML

Device Class : 1

Duns Number: 117359612

Premarket Exempt : No

Product Code : LKT

Prescription Use : Yes

Device Count : 1

D3 Duet - 30014613330929 Catalog Number : 01-215010

Device Description : D3 Duet DFA RSV Screening Reagent

Device Class : 1

Duns Number: 117359612

Premarket Exempt : No

Product Code : LKT

Prescription Use : Yes

Device Count : 1

D3 - 30014613330950 Catalog Number : 01-320000

Device Description : DOUBLE DUET RESPIRATORY KIT

Device Class : 1

Duns Number: 117359612

Premarket Exempt : Yes

Product Code : LKT

Prescription Use : Yes

Device Count : 1

DHI Media & Controls - 30014613330967 Catalog Number : 03-05000

Device Description : C. DIFFICILE TOXIN DETECTION

Device Class : 1

Duns Number: 117359612

Premarket Exempt : Yes

Product Code : KIP

Prescription Use : Yes

Device Count : 1

DHI Media & Controls - 30014613330974 Catalog Number : 03-05050

Device Description : C. DIFFICILE SPEC. DILUENT

Device Class : 1

Duns Number: 117359612

Premarket Exempt : Yes

Product Code : KIP

Prescription Use : Yes

Device Count : 1

DHI Media & Controls - 30014613330981 Catalog Number : 03-05130

Device Description : C. DIFFICILE TOXIN Control

Device Class : 1

Duns Number: 117359612

Premarket Exempt : Yes

Product Code : KIP

Prescription Use : Yes

Device Count : 1

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