Mycoplasma genitalium macrolide resistance primers PRD-061107

GUDID 15430001412069

Oligonucleotides designed to detect the mutations associated to macrolide resistance on 23S RNA (A2058C, A2058G, A2058T, A2058C and A2059G)

Diagenode

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

• Primary Device ID: 15430001412069
• NIH Device Record Key: 198426a7-0b90-4170-a6d0-629ff6cc0e93
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mycoplasma genitalium macrolide resistance primers
• Version Model Number: 1
• Catalog Number: PRD-061107
• 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	15430001412069 [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: 2021-03-23Oligonucleotides designed to detect the mutations associated to macrolide resistance on 23S RNA (A2058C, A2058G, A2058T, A2058C and A2059G)
• 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: 2021-03-23 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