# Diagnostic Hybrids, Inc.

- Location (FDA's records): Athens, OH
- FDA decisions: 37 (1988–2014): 36 510(k) clearances and 1 De Novo grant
- Product codes: KIR (13), GQN (7), GNW (5), OMG (3), JZO (2), LJP (1), GQW (1), PGI (1), GQL (1), GQS (1), LKT (1), LIN (1)
- Predicates its devices cite: 31 (17 its own); citations of its devices by later devices: 19 (17 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Diagnostic Products Corp.: 3 (https://510kreport.com/company/diagnostic-products)
- Light Diagnostics: 3 (https://510kreport.com/company/light-diagnostics)
- Baxter Healthcare Corp: 2 (https://510kreport.com/company/baxter-healthcare)
- Syva Co.: 2 (https://510kreport.com/company/syva)
- American Micro Scan: 1 (https://510kreport.com/company/american-micro-scan)
- Kallestad Diag, A Div. of Erbamont, Inc.: 1 (https://510kreport.com/company/kallestad-diag-a-div-of-erbamont)
- Kronus Market Development Associates, Inc.: 1 (https://510kreport.com/company/kronus-market-development-associates)
- Prodesse, Inc.: 1 (https://510kreport.com/company/prodesse)

## Firms that cite its devices most
- Eragen Biosciences: 1 (https://510kreport.com/company/eragen-biosciences)
- Siemens Healthcare Diagnostics, Inc.: 1 (https://510kreport.com/company/siemens-healthcare-diagnostics)

## Its most-cited devices
- K061101: D3 Ultra Dfa Respiratory Virus Screening & ID Kit (2006), cited by 7
- K081928: D3 Duet Dfa RSV/Respiratory Virus Screening Kit (2008), cited by 4
- K090073: D3 Dfa Metapneumovirus Identification Kit (2009), cited by 2
- K971662: Elvis HSV ID/Typing Test System (1997), cited by 2
- K962306: Fresh Cells Multi-Well & Shell Vial Cultures (1996), cited by 1
- K092229: Thyretain TM Tsi Reporter Bioassay (2010), cited by 1

## Recent decisions
- DEN140004: Quidel Molecular Direct HSV 1 +2/VZV Assay (May 13, 2014)
- K092229: Thyretain TM Tsi Reporter Bioassay (May 18, 2010)
- K093415: D3 Fastpoint L-Dfa Parainfluenza Virus/Adenovirus Identification Kit (Dec 23, 2009)
- K093233: D3 Fastpoint L-Dfa RSV/MVP Identification Kit (Dec 4, 2009)
- K092882: D3 Fastpoint L-Dfa Influenza a/Influenza B Virus Identification Kit (Oct 21, 2009)
- K091171: D3 Ultra Duet Dfa Respiratory Virus Identification Kit (Sep 11, 2009)
- K092300: Modification to D3 Ultra Dfa Respiratory Virus Screening & ID Kit (Aug 28, 2009)
- K091753: Elvis HSV ID and D3 Typing Test System (Aug 28, 2009)

Source page: https://510kreport.com/company/diagnostic-hybrids