FDA.reportPublic FDA data

BioArray Assay Imaging SystemTM (AIS) 400C

Primary DI
10888234102205
Brand
BioArray Assay Imaging SystemTM (AIS) 400C
Company
BIOARRAY SOLUTIONS LTD
Model
790-20006
Catalog number
790-20006
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
10888234102205PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088823410220510888234102205

GMDN Terms#

Term, Definition table
TermDefinition
Microarray analyser IVD, semi-automatedA mains electricity (AC-powered) laboratory instrument intended to be used for the in vitro determination of multiple target analytes in a single clinical specimen using oligonucleotide capture molecules arranged in a consistent pattern on a slide, chip or membrane. Identification of a target sequence in the clinical specimen is by hybridization of complementary base pairs, with a detection system typically using fluorophores, fluorescent-labelled dyes, and/or digital imaging techniques. The device operates with reduced technician involvement and automation of some, but not all, procedural steps.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00avoid exposure to direct sunlight
Special Storage Condition, Specify00temperature of 15 degrees Celsius to 26.7 degrees Celsius when in use
Storage Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
949103725
Device count
1
Serial number
true
Manufacturing 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
10888234102670Carrier Box, ETC, Slide, IVD800-20301800-203012014-09-24
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

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10190302019903Applied BioSystems™ JUN™ Dye Spectral Calibration Plate for Multiplex qPCR, FastLIFE TECHNOLOGIES HOLDINGS PTE. LTD.NSU2025-08-19
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06974849369403EudemonTM AIO800Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.NSU2024-11-14
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