FDA.reportPublic FDA data

Carrier Box, ETC, Slide, IVD

Primary DI
10888234102670
Brand
Carrier Box, ETC, Slide, IVD
Company
BIOARRAY SOLUTIONS LTD
Model
800-20301
Catalog number
800-20301
Published
2014-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
NSUInstrumentation For Clinical Multiplex Test Systems

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NSUInstrumentation For Clinical Multiplex Test SystemsClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK1300510

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK1300510

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10888234102670PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088823410267010888234102670

GMDN Terms#

Term, Definition table
TermDefinition
Optical instrument calibration/verification reference standard IVDA solid phase or sealed liquid reference standard of known optical and physical characteristics, intended to be used to verify the performance of a spectrophotometer or other optical instrument. The standard is typically presented as a solid/sealed cuvette or a multiple-well test plate and may include filters or a source of light emitted at specified wavelengths. Verification functions may include optical density (absorbance), fluorescent or luminescent accuracy, linearity, repeatability and/or limit of detection readings at specified wavelengths, and the ability to verify optical alignment and precision of the instrument or analyser. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
949103725
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10888234100065Immucor Precise TypeTM Human Erythrocyte Antigen Molecular BeadChip Test Slides800-20202-08800-20202-082014-09-24
10888234100621Filled Vial, Clean-up, 330uL800-00191800-001912014-09-24
10888234100645Filled Vial, eMAPTM Elongation Mix800-00193800-001932014-09-24
10888234100669Filled Vial, HEA 1.2 PCR Mix800-00194800-001942014-09-24
10888234100683Filled Vial, Lambda Exonuclease800-00195800-001952014-09-24
10888234100836Filled Vial,Negative Control 1mL800-00287800-002872014-09-24
10888234100928Filled Vial,HotStarTaq DNA Polymerase800-10242800-102422014-09-24
10888234102298BeadCheck HEA Ref-pA, Bulk and Fill800-00228800-002282014-09-24
10888234102328BeadCheck HEA Ref-pB, Bulk and Fill800-00229800-002292014-09-24
10888234102618Immucor Precise TypeTM Human Erythrocyte Antigen Molecular BeadChip Test Plate800-20202-96800-20202-962014-09-24
10888234102632Precise TypeTM HEA BeadCheck Kit800-20236800-202362014-09-24
10888234102205BioArray Assay Imaging SystemTM (AIS) 400C790-20006790-200062014-09-24
10888234102212BioArray Assay Imaging System TM (AIS) 400C790-20006-RF790-20006-RF2015-12-28
10888234102229BioArray Assay Imaging System TM (AIS) 400D790-20016790-200162015-08-06
10888234102236BioArray Assay Imaging System TM (AIS) 400D790-20016-RF790-20016-RF2015-08-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840487101438LIAISON PLEX Gastrointestinal Flex AssayLUMINEX CORPORATIONNSU2026-06-08
07613336206355cobas® 6800 systemRoche Molecular Systems, Inc.NSU2026-03-26
07613336206362cobas® 8800 systemRoche Molecular Systems, Inc.NSU2026-03-26
04049016126034EUROArrayScanEUROIMMUN Medizinische Labordiagnostika AGNSU2025-12-19
00851458005327SPOTFIRE Control Station - ITARBIOFIRE DEFENSE, LLCNSU2025-12-16
00851458005334SPOTFIRE Control Station - non-ITARBIOFIRE DEFENSE, LLCNSU2025-12-16
05060441760005binx ioBINX HEALTH LIMITEDNSU2025-09-03
10190302019897Applied BioSystems™ ABY™ Dye Spectral Calibration Plate for Multiplex qPCR, FastLIFE TECHNOLOGIES HOLDINGS PTE. LTD.NSU2025-08-19
10190302019903Applied BioSystems™ JUN™ Dye Spectral Calibration Plate for Multiplex qPCR, FastLIFE TECHNOLOGIES HOLDINGS PTE. LTD.NSU2025-08-19
00840487101858LIAISON PLEX Gram-Positive Blood Culture AssayLUMINEX CORPORATIONNSU2025-07-11
08033891322670CHORUS EVODIESSE DIAGNOSTICA SENESE SPANSU2025-07-01
00840487101841LIAISON PLEX Gram-Negative Blood Culture AssayLUMINEX CORPORATIONNSU2025-06-11
04719880531103QLociLIFEOS GENOMICS CORPORATIONNSU2025-04-30
00850063063005DASH® Rapid PCR InstrumentNuclein, LLCNSU2025-01-06
00856826006203Applied BiosystemsAffymetrix, Inc.NSU2024-12-24
15420045517059Aptima®Hologic, Inc.NSU2024-12-19
15420045517066Aptima®Hologic, Inc.NSU2024-12-19
15420045517073Aptima®Hologic, Inc.NSU2024-12-19
15420045517080Aptima®Hologic, Inc.NSU2024-12-19
06974849369403EudemonTM AIO800Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.NSU2024-11-14
00815381020727BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel MiniBIOFIRE DIAGNOSTICS, LLCNSU2024-07-26
00840487101957LIAISON PLEX® ChassisLUMINEX CORPORATIONNSU2024-06-20
00840487101964LIAISON PLEX® Chassis (Refurbished)LUMINEX CORPORATIONNSU2024-06-20
00840487101971LIAISON PLEX® ModuleLUMINEX CORPORATIONNSU2024-06-20
00840487101988LIAISON PLEX® Module (Refurbished)LUMINEX CORPORATIONNSU2024-06-20
00875197006926cobas Buffer Negative Control KitRoche Diagnostics GmbHNSU2024-06-05
00815381020390BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) PanelBIOFIRE DIAGNOSTICS, LLCNSU2024-05-03
00382904439767BD Vaginal Panel on BD COR SystemBECTON, DICKINSON AND COMPANYNSU2024-04-02
00851458005297FILMARRAY® COMMERCIAL LAPTOPBIOFIRE DEFENSE, LLCNSU2024-03-19
00195126000871Aptiva® System Cleaning Solution KitINOVA DIAGNOSTICS, INC.NSU2024-03-18