41 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Canada
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DNA GENOTEK, INC.
FDA registration
DNA GENOTEK, INC.·10 products·🇨🇦 Canada
ORAcollect DNA
Device
EU MDR
·
Eu Md Class 1
·DNA Genotek Inc.·On the market·32 countries
ORAgene DNA
Device
EU IVDR
·
Eu Ivd Class A
·DNA Genotek Inc.·On the market·32 countries
ORAgene DNA
Device
EU IVDR
·
Eu Ivd Class A
·DNA Genotek Inc.·On the market·32 countries
ORAgene DNA
Device
EU IVDR
·
Eu Ivd Class A
·DNA Genotek Inc.·On the market·32 countries
ORAgene DNA
Device
EU IVDR
·
Eu Ivd Class A
·DNA Genotek Inc.·On the market·32 countries
ORAgene DNA
Device
EU IVDR
·
Eu Ivd Class A
·DNA Genotek Inc.·On the market·32 countries
ORAgene DNA
Device
EU IVDR
·
Eu Ivd Class A
·DNA Genotek Inc.·On the market·32 countries
PrepIT Q2A Kit, Model PT-Q2A-96 containing component reagent AG (PT-QAG-96) 1.4mL and ST (PT-QST-96) 2.9mL - Product Usage: used for the removal of SDS and other inhibitors from samples collected using DNA Genotek oral sample collection kits.
FDA Enforcement
Class III
·Terminated·DNA Genotek Inc.·September 30, 2020
ORAcollect RNA: ORE-100
FDA Enforcement
Class II
·Ongoing·DNA Genotek Inc.·April 27, 2022
ORAcollect Dx, Catalog Number/SKU: OCD-100, OCD-100A. Material numbers: OCD-100, OCD-100.008, OCD-100.012, OCD-100.014+ACP078, OCD-100.014+ACP078, OCD-100.032 and OCD-100A, OCD-100A.022, OCD-100A.023, OCD-100A.024, OCD-100A.025
FDA Enforcement
Class II
·Ongoing·DNA Genotek Inc.·April 27, 2022
REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
Device
EU IVDR
·
Eu Ivd Class A
·Norgen Biotek Corporation·On the market
REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
Device
EU IVDR
·
Eu Ivd Class A
·Norgen Biotek Corporation·On the market
REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
Device
EU IVDR
·
Eu Ivd Class A
·Norgen Biotek Corporation·On the market
REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
Device
EU IVDR
·
Eu Ivd Class A
·Norgen Biotek Corporation·On the market
REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
Device
EU IVDR
·
Eu Ivd Class A
·Norgen Biotek Corporation·On the market
REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
Device
EU IVDR
·
Eu Ivd Class A
·Norgen Biotek Corporation·On the market
REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
Device
EU IVDR
·
Eu Ivd Class A
·Norgen Biotek Corporation·On the market
REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
Device
EU IVDR
·
Eu Ivd Class A
·Norgen Biotek Corporation·On the market
REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
Device
EU IVDR
·
Eu Ivd Class A
·Norgen Biotek Corporation·On the market