D3 DUET DFA INFLUENZA A/RESPIRATORY VIRUS SCREENING KIT

Antisera, Cf, Influenza Virus A, B, C

DIAGNOSTIC HYBRIDS, INC.

The following data is part of a premarket notification filed by Diagnostic Hybrids, Inc. with the FDA for D3 Duet Dfa Influenza A/respiratory Virus Screening Kit.

Pre-market Notification Details

• Device ID: K081746
• 510k Number: K081746
• Device Name: D3 DUET DFA INFLUENZA A/RESPIRATORY VIRUS SCREENING KIT
• Classification: Antisera, Cf, Influenza Virus A, B, C
• Applicant: DIAGNOSTIC HYBRIDS, INC. 1055 EAST STATE STREET SUITE 100 Athens, OH 45701
• Contact: Gail R Goodrum
• Correspondent: Gail R Goodrum; DIAGNOSTIC HYBRIDS, INC. 1055 EAST STATE STREET SUITE 100 Athens, OH 45701
• Product Code: GNW
• CFR Regulation Number: 866.3330 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-06-19
• Decision Date: 2008-12-23
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
30014613330882	K081746	000