Mycoplasma genitalium macrolide resistance probes

GUDID 15430001412076

Oligunucleotides designed to detect mutations associated to macrolide resistance on 23S RNA (A2058C, 2058G, 2058T, 2059C, A2059G). These oligonucleotides contain a 5' FAM label and a 3' BHQ-1 label

Diagenode

Mycoplasma genitalium nucleic acid IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 15430001412076
• NIH Device Record Key: 73c40cd5-75d0-43bb-902c-1ab53b32f741
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mycoplasma genitalium macrolide resistance probes
• Version Model Number: 1
• Company DUNS: 373050462
• Company Name: Diagenode
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	15430001412076 [Primary]

FDA Product Code

• MVU: Reagents, Specific, Analyte

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-23
• Device Publish Date: 2021-03-15

Devices Manufactured by Diagenode

• 15430001412069 - Mycoplasma genitalium macrolide resistance primers: 2021-03-23 Oligonucleotides designed to detect the mutations associated to macrolide resistance on 23S RNA (A2058C, A2058G, A2058T, A2058C
• 15430001412076 - Mycoplasma genitalium macrolide resistance probes: 2021-03-23Oligunucleotides designed to detect mutations associated to macrolide resistance on 23S RNA (A2058C, 2058G, 2058T, 2059C, A2059G). These oligonucleotides contain a 5' FAM label and a 3' BHQ-1 label
• 15430001412076 - Mycoplasma genitalium macrolide resistance probes: 2021-03-23 Oligunucleotides designed to detect mutations associated to macrolide resistance on 23S RNA (A2058C, 2058G, 2058T, 2059C, A2059G
• 15430001412083 - Mycoplasma genitalium Macrolide Resistance IVT A2058C Control: 2021-03-23 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 Controls: 2021-03-23 In vitro transcript of Mycoplasma genitalium 23S RNA including A2058T mutation
• 15430001412113 - Mycoplasma genitalium macrolide resistance IVT A2059C Control: 2021-03-23 In vitro transcript of Mycoplama genitalium 23S RNA including A 2059C mutation
• 15430001412120 - Mycoplasma genitamium macrolide resistance IVT A 2059G control: 2021-03-23 In vitro transcript of mycoplasma genitalium 23S RNA including A2059G mutation
• 15430001412137 - Mycoplama genitalium IVT Wild type control: 2021-03-23 In vitro transcript of Mycoplasma genitalium 23S RNA