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Diagnostic Hybrids, Inc.

FDA Regulatory Profile

Summary

Total Recalls
8
510(k) Clearances
37
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1496-2018Class IIMicroVue CIC-C1q EIA, Model A001. An enzyme immunoassay for the detection of circulating immune comApril 4, 2017
Z-1520-2018Class IIIQuidel MicroVue Intact PTH EIA, Model 8044. An enzyme immunoassay for the quantification of Intact October 26, 2016
Z-1797-2018Class IIMicroVue BAP EIA, Model 8012, provides a quantitative measure of bone-specific alkaline phosphatase July 14, 2016
Z-1498-2018Class IIIMicroVue SC5b-9 Plus EIA (RUO), Model A020. Research use only (RUO) product. An enzyme immunoassay November 3, 2015
Z-1497-2018Class IIIMicroVue CIC-C1q EIA, Model A001. The MicroVue CIC-C1q EIA is for detection of circulating immune coNovember 3, 2015
Z-1499-2018Class IIIMicroVue SC5b-9 Plus EIA (CE-IVD), Model A029. An enzyme immunoassay for the quantitation of SC5b-9November 3, 2015
Z-0417-2015Class IIMicroVue Bb Plus EIA is packaged as a kit which contains all reagent components to perform the test.October 16, 2014
Z-0792-2013Class IIIDiagnostic Hybrids, Inc., RhMK, Model #:49-0600, 49-0600A, 49-0102A, and 49-T075A. Culture media, uDecember 31, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
DEN140004QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAYMay 13, 2014
K092229THYRETAIN TM TSI REPORTER BIOASSAYMay 18, 2010
K093415D3 FASTPOINT L-DFA PARAINFLUENZA VIRUS/ADENOVIRUS IDENTIFICATION KITDecember 23, 2009
K093233D3 FASTPOINT L-DFA RSV/MVP IDENTIFICATION KITDecember 4, 2009
K092882D3 FASTPOINT L-DFA INFLUENZA A/INFLUENZA B VIRUS IDENTIFICATION KITOctober 21, 2009
K091171D3 ULTRA DUET DFA RESPIRATORY VIRUS IDENTIFICATION KITSeptember 11, 2009
K092300MODIFICATION TO D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KITAugust 28, 2009
K091753ELVIS HSV ID AND D3 TYPING TEST SYSTEMAugust 28, 2009
K083391THYROID STIMULATING IMMUNOGLOBULIN REPORTER ASSAYMay 21, 2009
K090073D3 DFA METAPNEUMOVIRUS IDENTIFICATION KITMarch 6, 2009
K081746D3 DUET DFA INFLUENZA A/RESPIRATORY VIRUS SCREENING KITDecember 23, 2008
K081928D3 DUET DFA RSV/RESPIRATORY VIRUS SCREENING KITDecember 23, 2008
K081164D3 DFA CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN IDENTIFICATION KITJune 13, 2008
K070265DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION AND TYPING KIT, MODEL 01-090000October 24, 2007
K063675DIAGNOSTIC HYBRIDS' D3 DFA CHLAMYDIAE CULTURE CONFIRMATION KITSeptember 24, 2007
K063798DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION KIT, MODEL 01-080000September 21, 2007
K070206DIAGNOSTIC HYBRIDS D3 DFA VARICELLA-ZOSTER VIRUS IDENTIFICATION KIT, 01-020000August 30, 2007
K061101D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KITNovember 20, 2006
K022713DFA RESPIRATORY VIRUS SCREENING & ID KITDecember 18, 2002
K971662ELVIS HSV ID/TYPING TEST SYSTEMNovember 18, 1997