8 results
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48ms
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Sources: EU EUDAMED, US FDA
Inova Diagnostics BINDAZYME Human C1q binding Circulating Immune Complex EIA Kit, Part#: MK021
FDA Recall
Terminated
·Inova Diagnostics Incorporated·Product code DAK·October 28, 2009
QUANTA-Lyser 240 IFA, Part #GS0242. The instrument is a fully automated, high-throughput, bench top system designed for clinical use to automate slide and reagent barcode reading, sample dilution and distribution, reagent pipetting and dispensing, slide and plate washing, dispensing slide mounting medium in the preparation for microscope analysis, and photometric measurement of microwell plates.
FDA Recall
Terminated
·Inova Diagnostics Incorporated·Product code JJE·January 26, 2018
QUANTA-Lyser 240 EIA, Part #GS0241. The instrument is a fully automated, high-throughput, bench top system designed for clinical use to automate slide and reagent barcode reading, sample dilution and distribution, reagent pipetting and dispensing, slide and plate washing, dispensing slide mounting medium in the preparation for microscope analysis, and photometric measurement of microwell plates.
FDA Recall
Terminated
·Inova Diagnostics Incorporated·Product code JJE·January 26, 2018
Inova Diagnostic Inc., NOVA Lite ANA KSL Kit Part Number: 708390. in vitro diagnostic.
FDA Recall
Terminated
·Inova Diagnostics Incorporated·Product code DHN·September 26, 2011
QUANTA-Lyser 240 EIA, Part #GS0241. The instrument is a fully automated, high-throughput, bench top system designed for clinical use to automate slide and reagent barcode reading, sample dilution and distribution, reagent pipetting and dispensing, slide and plate washing, dispensing slide mounting medium in the preparation for microscope analysis, and photometric measurement of microwell plates.
FDA Enforcement
Class II
·Terminated·Inova Diagnostics Incorporated·April 4, 2018
QUANTA-Lyser 240 IFA, Part #GS0242. The instrument is a fully automated, high-throughput, bench top system designed for clinical use to automate slide and reagent barcode reading, sample dilution and distribution, reagent pipetting and dispensing, slide and plate washing, dispensing slide mounting medium in the preparation for microscope analysis, and photometric measurement of microwell plates.
FDA Enforcement
Class II
·Terminated·Inova Diagnostics Incorporated·April 4, 2018
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