Mycoplama genitalium IVT Wild type control

GUDID 15430001412137

In vitro transcript of Mycoplasma genitalium 23S RNA

Diagenode

Mycoplasma genitalium nucleic acid IVD, control
Primary Device ID15430001412137
NIH Device Record Key0afbce89-4005-44cb-863a-a7b77969ad55
Commercial Distribution StatusIn Commercial Distribution
Brand NameMycoplama genitalium IVT Wild type control
Version Model Number1
Company DUNS373050462
Company NameDiagenode
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS115430001412137 [Primary]

FDA Product Code

JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-03-23
Device Publish Date2021-03-15

Devices Manufactured by Diagenode

15430001412069 - Mycoplasma genitalium macrolide resistance primers2021-03-23 Oligonucleotides designed to detect the mutations associated to macrolide resistance on 23S RNA (A2058C, A2058G, A2058T, A2058C
15430001412076 - Mycoplasma genitalium macrolide resistance probes2021-03-23 Oligunucleotides designed to detect mutations associated to macrolide resistance on 23S RNA (A2058C, 2058G, 2058T, 2059C, A2059G
15430001412083 - Mycoplasma genitalium Macrolide Resistance IVT A2058C Control2021-03-23 In vitro transcript of Mycoplasma genitalium 23S RNA including A2058C mutation
15430001412090 - Mycoplasma genitalium macrolide resistance IVT A2058G Control 2021-03-23 In vitro transcript of Mycoplasma genitalium 23S RNA including A2058G mutation
15430001412106 - Mycoplasma genitalium macrolide resistance IVT A2058T Controls2021-03-23 In vitro transcript of Mycoplasma genitalium 23S RNA including A2058T mutation
15430001412113 - Mycoplasma genitalium macrolide resistance IVT A2059C Control2021-03-23 In vitro transcript of Mycoplama genitalium 23S RNA including A 2059C mutation
15430001412120 - Mycoplasma genitamium macrolide resistance IVT A 2059G control2021-03-23 In vitro transcript of mycoplasma genitalium 23S RNA including A2059G mutation
15430001412137 - Mycoplama genitalium IVT Wild type control2021-03-23In vitro transcript of Mycoplasma genitalium 23S RNA
15430001412137 - Mycoplama genitalium IVT Wild type control2021-03-23 In vitro transcript of Mycoplasma genitalium 23S RNA

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.