FDA.reportPublic FDA data

Q-Vera Prima 96 qPCR Instrument

Primary DI
06955792701670
Brand
Q-Vera Prima 96 qPCR Instrument
Company
Sansure Biotech Inc.
Model
96-well, 0.2 mL block (Model: Q-Vera Prima 96 AF40
Device description
For qualitative, quantitative, or melting curve analysis of nucleic acid samples derived from research specimens. For research use only.
Published
2025-10-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
OOIReal Time Nucleic Acid Amplification System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OOIReal Time Nucleic Acid Amplification SystemClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06955792701670PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06955792701670069557927016706955792701670

GMDN Terms#

Term, Definition table
TermDefinition
Thermal cycler nucleic acid amplification analyser IVD, laboratoryAn electrically-powered automated or semi-automated laboratory instrument intended to amplify target deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) in a clinical specimen using heat-stable polymerase enzymes and cycles of repeated heating and cooling (i.e., thermal cycling) to replicate a product [i.e., a polymerase chain reaction (PCR)]. Amplified product is detected and/or quantified using oligonucleotide markers as it is produced (i.e., in real-time) or at the end-point. The analyser may also isolate, extract and/or prepare nucleic acid from the clinical specimen and/or culture isolate prior to amplification.

Contacts#

Phone, Email table
PhoneEmail
(203) 726-7873support@lusisbio.com

Regulatory Flags#

DUNS number
421167832
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06955792702844Nucleic Acid Extraction and Purification Kit 1.0Xvance 48C2026-03-25
06955792702851Nucleic Acid Extraction and Purification Kit 1.0Xvance 96A2026-03-25
06955792702868Nucleic Acid Extraction and Purification Kit 2.0Xvance 482026-03-25
06955792702875Nucleic Acid Extraction and Purification Kit 2.0Xvance 962026-03-25
06955792702882Nucleic Acid Extraction and Purification Kit 3.0Xvance 48A2026-03-25
06955792702899Nucleic Acid Extraction and Purification Kit 3.0Xvance 48B2026-03-25
06955792701717Q-Vera Prima 96 qPCR Instrument96-well, 0.2 mL block (Model: Q-Vera Prima 96 TAMR2025-11-19
06955792700857Q-Vera Pico 6X qPCR Instrument48-well (8 wells x 6), 0.2 mL blocks2025-09-18
06955792701557Sample Storage ReagentLU-X1002E-48-62025-09-18
06955792701564Sample Storage ReagentLU-X1002E-48-32025-09-18
06955792701571Sample Storage ReagentLU-X1002E-48-12025-09-18
06955792701649Sample Storage ReagentLU-X1002E-48-3b2025-09-18
06955792701656Sample Storage ReagentLU-X1002E-48-6b2025-09-18
06955792700864Q-Vera Prima 96 qPCR Instrument96-well, 0.2 mL block2024-10-29
06955792714977Nucleic Acid Extraction-Purification Kit 4.0S50016E-48B2023-09-18
06955792714960Nucleic Acid Extraction-Purification Kit 4.0S50016E-48A2023-09-15
06955792714694NATCH S-F11C SystemS-F11C (US)2023-08-10
06955792713666Nucleic Acid Extraction-Purification Kit 3.0S50016E-482023-07-28
06955792713673Nucleic Acid Extraction-Purification Kit 3.0S50016E-962023-07-28
06955792714366Nucleic Acid Extraction-Purification Kit 2.0S50016E-48C2023-07-26

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