FDA.reportPublic FDA data

Mycoplasma genitalium macrolide resistance IVT A2058G Control

Primary DI
15430001412090
Brand
Mycoplasma genitalium macrolide resistance IVT A2058G Control
Company
Diagenode
Model
1
Catalog number
PRD-06110
Device description
In vitro transcript of Mycoplasma genitalium 23S RNA including A2058G mutation
Published
2021-03-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)Clinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15430001412090PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1543000141209015430001412090

GMDN Terms#

Term, Definition table
TermDefinition
Mycoplasma genitalium nucleic acid IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid from Mycoplasma genitalium bacteria in a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
373050462
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15430001412069Mycoplasma genitalium macrolide resistance primers1PRD-0611072021-03-15
15430001412076Mycoplasma genitalium macrolide resistance probes12021-03-15
15430001412083Mycoplasma genitalium Macrolide Resistance IVT A2058C Control1PRD-061092021-03-15
15430001412106Mycoplasma genitalium macrolide resistance IVT A2058T Controls1PRD-061112021-03-15
15430001412113Mycoplasma genitalium macrolide resistance IVT A2059C Control12021-03-15
15430001412120Mycoplasma genitamium macrolide resistance IVT A 2059G control1PRD-061132021-03-15
15430001412137Mycoplama genitalium IVT Wild type control12021-03-15

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00021292008420TRUE FOCUSTRIVIDIA HEALTH, INC.JJX2021-02-26
00021292008437TRUE FOCUSTRIVIDIA HEALTH, INC.JJX2021-02-26
00021292008444TRUE FOCUSTRIVIDIA HEALTH, INC.JJX2021-02-26
00021292008369TRUEcontrolTRIVIDIA HEALTH, INC.JJX2021-01-29
00021292008383TRUEcontrolTRIVIDIA HEALTH, INC.JJX2021-01-29
14987481164441uTASWako AFP-L3 Control LFUJIFILM WAKO PURE CHEMICAL CORPORATIONJJX2020-10-23
14987481164458uTASWako AFP-L3 Control HFUJIFILM WAKO PURE CHEMICAL CORPORATIONJJX2020-10-23
14987481164489uTASWako DCP Control LFUJIFILM WAKO PURE CHEMICAL CORPORATIONJJX2020-10-23
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00021292008390TRUE METRIXTRIVIDIA HEALTH, INC.JJX2020-10-21