FDA.reportPublic FDA data

Q-Vera Prima 96 qPCR Instrument

Primary DI
06955792701717
Brand
Q-Vera Prima 96 qPCR Instrument
Company
Sansure Biotech Inc.
Model
96-well, 0.2 mL block (Model: Q-Vera Prima 96 TAMR
Device description
For qualitative, quantitative, or melting curve analysis of nucleic acid samples derived from research specimens. For research use only.
Published
2025-11-19
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
06955792701717PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06955792701717069557927017176955792701717

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
06955792701670Q-Vera Prima 96 qPCR Instrument96-well, 0.2 mL block (Model: Q-Vera Prima 96 AF402025-10-16
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850028489017MyrnaInflammatix, Inc.OOI2026-04-30
00850028489024TriVerityInflammatix, Inc.OOI2026-04-30
00875197005240cobas® Cdiff TestRoche Molecular Systems, Inc.OOI2026-02-24
00875197005288cobas® 4800 Cdiff Controls and Cofactor KitRoche Molecular Systems, Inc.OOI2026-02-24
00875197005677cobas® CdiffRoche Molecular Systems, Inc.OOI2026-02-23
00875197005684cobas® Cdiff Control KitRoche Molecular Systems, Inc.OOI2026-02-23
10816101025142LIAISON NES® InstrumentDIASORIN MOLECULAR LLCOOI2026-01-22
10816101025159LIAISON NES® Instrument (Refurbished)DIASORIN MOLECULAR LLCOOI2026-01-22
20816101029031LIAISON NES® FLU A/B, RSV & COVID-19DIASORIN MOLECULAR LLCOOI2026-01-22
20816101029048LIAISON NES® FLU A/B, RSV & COVID-19 Control Swab KitDIASORIN MOLECULAR LLCOOI2026-01-22
07332940009694GeneXpert®CEPHEIDOOI2026-01-19
07332940009700GeneXpert® XpressCEPHEIDOOI2026-01-19
20816101027358Simplexa COVID-19 / Flu A/B & RSV DirectDIASORIN MOLECULAR LLCOOI2026-01-14
20816101027365Simplexa COVID-19 / Flu A/B & RSV Positive Control PackDIASORIN MOLECULAR LLCOOI2026-01-14
30382904452798Enteric Bacterial Panel Diluent for BD COR™ SystemBECTON, DICKINSON AND COMPANYOOI2025-12-09
00382904448721BD Enteric Bacterial Panel plus for BD COR™ SystemBECTON, DICKINSON AND COMPANYOOI2025-12-09
00382904448738BD Enteric Bacterial Panel for BD COR™ SystemBECTON, DICKINSON AND COMPANYOOI2025-12-09
00382904452797Enteric Bacterial Panel Diluent for BD COR™ SystemBECTON, DICKINSON AND COMPANYOOI2025-12-09
06955792701670Q-Vera Prima 96 qPCR InstrumentSansure Biotech Inc.OOI2025-10-16
15420045517486Panther Fusion®Hologic, Inc.OOI2025-10-07
15420045517493Panther Fusion®Hologic, Inc.OOI2025-10-07
15420045517509Panther Fusion®Hologic, Inc.OOI2025-10-07
15420045517516Panther Fusion®Hologic, Inc.OOI2025-10-07
06955792700857Q-Vera Pico 6X qPCR InstrumentSansure Biotech Inc.OOI2025-09-18
04053228041849QIAstat-Dx® RiseQIAGEN GmbHOOI2025-09-05
07332940009687GeneXpert®CEPHEIDOOI2025-08-15
00811877012153ID NOW InstrumentAlere Scarborough, Inc.OOI2025-08-01
10190302019859Diomni™ Software, Version 4.2.0LIFE TECHNOLOGIES HOLDINGS PTE. LTD.OOI2025-05-02
06973843220802careSTART™ Q1 AmplifierHangzhou Bioer Technology Co., Ltd.OOI2025-02-11
06955792700864Q-Vera Prima 96 qPCR InstrumentSansure Biotech Inc.OOI2024-10-29