FDA.reportPublic FDA data

Accula Programming Cassette

Primary DI
B540D20010
Brand
Accula Programming Cassette
Company
MESA BIOTECH, INC.
Model
D2001
Catalog number
D2001
Device description
The Programming Cassette is an accessory to the Accula Dock and facilitates reprogramming of the Dock’s embedded firmware. When firmware updates are needed, the firmware will be stored onto Programming Cassettes and sent to end users, who will load the Programming Cassette into their Dock and re-program its firmware
Published
2020-06-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OCCRespiratory Virus Panel Nucleic Acid Assay System
OZEInfluenza A And Influenza B Multiplex Nucleic Acid Assay
QJRReagents, 2019-Novel Coronavirus Nucleic Acid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OCCRespiratory Virus Panel Nucleic Acid Assay SystemMicrobiology2
OZEInfluenza A And Influenza B Multiplex Nucleic Acid AssayMicrobiology2
QJRReagents, 2019-Novel Coronavirus Nucleic AcidUnknownN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B540D20010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Thermal cycler nucleic acid amplification analyser IVD, point-of-careA portable, electrically-powered instrument intended to be used by health professionals at the point-of-care 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 identified 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Handling Environment Temperature15 Degrees Celsius30 Degrees Celsius
Handling Environment Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
858-800-4929info@mesabiotech.com

Regulatory Flags#

DUNS number
056865474
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B540FAB1100CWC0Accula Flu A / B Control KitFAB1100CW-CFAB1100CW-12022-10-17
B540D20000Accula Dock D2000D20002020-04-13
B54010240 Silaris Influenza A&B Control Kit102410242018-03-15
B54010260Silaris Dock102610262018-03-15
B54010280SilarisTM Influenza A&B Starter Pack102810282018-03-15
B540FAB1100CW0Accula Flu A / B TestFAB1100CWFAB1100CW2022-10-17
B540COV4100010Accula SARS CoV-2 Control KitCOV4100-1COV4100-12020-05-19
B540COV41000Accula SARS-CoV-2 TestCOV4100COV41002020-04-13
B54010400Silaris RSV Supplemental Pack104010402019-07-29
B54010290Silaris RSV Control Kit102910292019-07-29
B54010300Silaris RSV Test103010302019-07-29
B54010350Sialris Influenza A&B Supplemental Pack103510352019-07-29
B54010270Silaris Influenza A&B Test102710272018-03-15

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00815381020390BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) PanelBIOFIRE DIAGNOSTICS, LLCOCC2024-05-03
00815381020390BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) PanelBIOFIRE DIAGNOSTICS, LLCOZE2024-05-03
00815381020765BIOFIRE® SPOTFIRE® Respiratory (R) Panel MiniBIOFIRE DIAGNOSTICS, LLCOZE2023-05-09
00815381020765BIOFIRE® SPOTFIRE® Respiratory (R) Panel MiniBIOFIRE DIAGNOSTICS, LLCOCC2023-05-09
00815381020659BIOFIRE ® SPOTFIRE ® Respiratory (R) PanelBIOFIRE DIAGNOSTICS, LLCOZE2023-04-06
00815381020659BIOFIRE ® SPOTFIRE ® Respiratory (R) PanelBIOFIRE DIAGNOSTICS, LLCOCC2023-04-06
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