Medical Device Manufacturer · US , Athens , OH

Diagnostic Hybrids, Inc.

37 submissions · 36 cleared · Since 1988
37
Total
36
Cleared
1
Denied

Diagnostic Hybrids, Inc. has 36 FDA 510(k) cleared microbiology devices. Based in Athens, US.

Historical record: 36 cleared submissions from 1988 to 2010.

Browse the complete list of FDA 510(k) cleared microbiology devices from this manufacturer. Filter by specialty or product code using the sidebar.

37 devices
1–12 of 37
QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAY
DEN140004 · PGI Herpes Virus (vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples · Microbiology
May 2014 81d
THYRETAIN TM TSI REPORTER BIOASSAY
K092229 · JZO System, Test, Thyroid Autoantibody · Immunology
May 2010 299d
D3 FASTPOINT L-DFA PARAINFLUENZA VIRUS/ADENOVIRUS IDENTIFICATION KIT
K093415 · GQS Antigens, Cf (including Cf Control), Parainfluenza Virus 1-4 · Microbiology
Dec 2009 51d
D3 FASTPOINT L-DFA RSV/MVP IDENTIFICATION KIT
K093233 · OMG Antisera, Fluorescent, Human Metapneumovirus · Microbiology
Dec 2009 51d
D3 FASTPOINT L-DFA INFLUENZA A/INFLUENZA B VIRUS IDENTIFICATION KIT
K092882 · GNW Antisera, Cf, Influenza Virus A, B, C · Microbiology
Oct 2009 33d
D3 ULTRA DUET DFA RESPIRATORY VIRUS IDENTIFICATION KIT
K091171 · OMG Antisera, Fluorescent, Human Metapneumovirus · Microbiology
Sep 2009 142d
ELVIS HSV ID AND D3 TYPING TEST SYSTEM
K091753 · GQL Antisera, Fluorescent, Herpesvirus Hominis 1,2 · Microbiology
Aug 2009 73d
MODIFICATION TO D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT
K092300 · GNW Antisera, Cf, Influenza Virus A, B, C · Microbiology
Aug 2009 30d
THYROID STIMULATING IMMUNOGLOBULIN REPORTER ASSAY
K083391 · JZO System, Test, Thyroid Autoantibody · Immunology
May 2009 185d
D3 DFA METAPNEUMOVIRUS IDENTIFICATION KIT
K090073 · OMG Antisera, Fluorescent, Human Metapneumovirus · Microbiology
Mar 2009 53d
D3 DUET DFA INFLUENZA A/RESPIRATORY VIRUS SCREENING KIT
K081746 · GNW Antisera, Cf, Influenza Virus A, B, C · Microbiology
Dec 2008 187d
D3 DUET DFA RSV/RESPIRATORY VIRUS SCREENING KIT
K081928 · LKT Respiratory Syncytial Virus, Antigen, Antibody, Ifa · Microbiology
Dec 2008 169d

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