Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

D3 DUET DFA RSV/RESPIRATORY VIRUS SCREENING KIT

K-Number: K081928 · 2008-12-23

ApplicantDiagnostic Hybrids, Inc.
Decision Date2008-12-23
Product CodeLKT
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

D3 DUET DFA RSV/RESPIRATORY VIRUS SCREENING KIT is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Hybrids, Inc.. It received FDA 510(k) clearance on 2008-12-23 under 510(k) number K081928. The device is classified under product code LKT. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the D3 DUET DFA RSV/RESPIRATORY VIRUS SCREENING KIT?

D3 DUET DFA RSV/RESPIRATORY VIRUS SCREENING KIT is a medical device that received FDA 510(k) clearance on 2008-12-23. The listed applicant is Diagnostic Hybrids, Inc.. The 510(k) number is K081928.

When did D3 DUET DFA RSV/RESPIRATORY VIRUS SCREENING KIT receive FDA 510(k) clearance?

D3 DUET DFA RSV/RESPIRATORY VIRUS SCREENING KIT received FDA 510(k) clearance on 2008-12-23, under 510(k) number K081928.

Who is the listed applicant for D3 DUET DFA RSV/RESPIRATORY VIRUS SCREENING KIT?

The FDA 510(k) record lists Diagnostic Hybrids, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for D3 DUET DFA RSV/RESPIRATORY VIRUS SCREENING KIT?

The FDA product code for D3 DUET DFA RSV/RESPIRATORY VIRUS SCREENING KIT is LKT.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Diagnostic Hybrids, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K092229THYRETAIN TM TSI REPORTER BIOASSAYK093415D3 FASTPOINT L-DFA PARAINFLUENZA VIRUS/ADENOVIRUS IDENTIFICATION KITK093233D3 FASTPOINT L-DFA RSV/MVP IDENTIFICATION KITK092882D3 FASTPOINT L-DFA INFLUENZA A/INFLUENZA B VIRUS IDENTIFICATION KITK091171D3 ULTRA DUET DFA RESPIRATORY VIRUS IDENTIFICATION KITK092300MODIFICATION TO D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT

View all 36 devices →

Related Devices (Code: LKT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K983336PATHODX RESPIRATORY VIRUS PANEL MODEL PKRP1Diagnostic Products Corp.K943317PATHODX RESPIRATORY SYNCYTIAL VIRUS (RSV)Diagnostic Products Corp.K942173RSV ANTIGEN TESTNeogenexK912842RSV-MAB TESTGull Laboratories, Inc.K912838BARTELS RESPIRATORY SYNCYTIAL VIRUS ENZYME IMMUNOBaxter Diagnostics, Inc.K912371BIOMERIEUX RSV DIRECT IF KITVitek Systems, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑