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)

DIAGNOSTIC HYBRIDS D3 DFA VARICELLA-ZOSTER VIRUS IDENTIFICATION KIT, 01-020000

K-Number: K070206 · 2007-08-30

ApplicantDiagnostic Hybrids, Inc.
Decision Date2007-08-30
Product CodeGQW
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

DIAGNOSTIC HYBRIDS D3 DFA VARICELLA-ZOSTER VIRUS IDENTIFICATION KIT, 01-020000 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 2007-08-30 under 510(k) number K070206. The device is classified under product code GQW. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIAGNOSTIC HYBRIDS D3 DFA VARICELLA-ZOSTER VIRUS IDENTIFICATION KIT, 01-020000?

DIAGNOSTIC HYBRIDS D3 DFA VARICELLA-ZOSTER VIRUS IDENTIFICATION KIT, 01-020000 is a medical device that received FDA 510(k) clearance on 2007-08-30. The listed applicant is Diagnostic Hybrids, Inc.. The 510(k) number is K070206.

When did DIAGNOSTIC HYBRIDS D3 DFA VARICELLA-ZOSTER VIRUS IDENTIFICATION KIT, 01-020000 receive FDA 510(k) clearance?

DIAGNOSTIC HYBRIDS D3 DFA VARICELLA-ZOSTER VIRUS IDENTIFICATION KIT, 01-020000 received FDA 510(k) clearance on 2007-08-30, under 510(k) number K070206.

Who is the listed applicant for DIAGNOSTIC HYBRIDS D3 DFA VARICELLA-ZOSTER VIRUS IDENTIFICATION KIT, 01-020000?

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 DIAGNOSTIC HYBRIDS D3 DFA VARICELLA-ZOSTER VIRUS IDENTIFICATION KIT, 01-020000?

The FDA product code for DIAGNOSTIC HYBRIDS D3 DFA VARICELLA-ZOSTER VIRUS IDENTIFICATION KIT, 01-020000 is GQW.

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 KITK091753ELVIS HSV ID AND D3 TYPING TEST SYSTEM

View all 36 devices →

Related Devices (Code: GQW)

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.

K990141LIGHT DIAGNOSTICS SIMULFLUOR HSV/VZV IMMUNOFLOURESCENCE ASSAY, MODEL 3295Light DiagnosticsK964872VZV ANTIGEN CONTROL SLIDESViral Antigens, Inc.K942743VIRO VARICELLA-ZOSTER VIRUS IDENTIFICATION REAGENTViro Research, Inc.K912239VZVSCAN(TM) LATEX AGGUTINATION TESTBd Becton Dickinson Vacutainer Systems PreanalyticK903882VARICELLA-ZOSTER VIRUS ANTIBODY TEST KIT-LATEX AGGViral Antigens, Inc.K894622VARICELLA ZOSTER VIRUSBion Ent., Ltd.

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.

↑