FDA.reportPublic FDA data

ASI Infinity Analyzer

Primary DI
00816057020058
Brand
ASI Infinity Analyzer
Company
ARLINGTON SCIENTIFIC, INC.
Model
NC-2700-000
Catalog number
NC-2700-000
Device description
EIA microtiter plate analyzer
Published
2016-07-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
JJQColorimeter, Photometer, Spectrophotometer For Clinical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJQColorimeter, Photometer, Spectrophotometer For Clinical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816057020058PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816057020058008160570200588160570200580816057020058

GMDN Terms#

Term, Definition table
TermDefinition
Microplate reader IVD, automatedA mains electricity (AC-powered) laboratory instrument intended to be used to photometrically measure the optical absorbance or emission of clinical specimens in microplates containing multiple individual sample wells, with or without a separate cuvette-reading station. The device utilizes technology which may include reagent dispensing, a single or dual lightsource, bandpass filters, monochromators, photodetectors, data processing software and/or data displays to determine the qualitative and/or quantitative values of biological constituents of a clinical specimen. The device operates with minimal technician involvement and complete automation of all procedural steps.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Area/Surface Area1.99Square meter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Room Temperature

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
801-489-8911info@arlingtonscientific.com

Regulatory Flags#

DUNS number
785966607
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816057021666ASI EvolutionNC-2800-000NC-2800-0002023-12-19
00816057021673ASI RPR Test for Syphilis for Use on the ASI EvolutionNC-900480ABBNC-900480ABB2023-12-19
00816057021680ASI RPR Test for Syphilis for Use on the ASI EvolutionNC-9004800ABBNC-9004800ABB2023-12-19
00816057021697ASI RPR Automated Control Set NC-905002.5ANC-905002.5A2023-12-19
00816057021703ASI RPR Automated Control Set NC-905005ANC905005A2023-12-19
00816057021710ASI Evolution RPR Titration DiluentNC-5300-905ANC-5300-905A2023-12-19
00816057021796ASI RPR Card Test for SyphilisNC-900100EXNC-900100EX2023-12-19
00816057021802ASI RPR Card Test for SyphilisNC-900500EXNC-900500EX2023-12-19
00816057021826ASI Color Staph Latex TestNC-285-050NC-285-0502023-12-19
00816057021833ASI Color Staph Latex TestNC-285-050NC-285-0502023-12-19
00816057021840ASI Color Staph Latex TestNC-285-300NC-285-3002023-12-19
00816057020409ASI Rubella TestNC-600030NC-6000302016-07-08
00816057020416ASI Rubella Test NC-600030ENC-600030E2016-07-08
00816057020423ASI Rubella TestNC-600100NC-6001002016-07-08
00816057020430ASI Rubella TestNC-600100ENC-600100E2016-07-08
00816057020447ASI Rubella TestNC-600500NC-6005002016-07-08
00816057020454ASI Rubella TestNC-600500ENC-600500E2016-07-08
00816057020041ASiManager-ATNC-2400-0BTNC-2400-0BT2016-07-08
00816057021628ASI CRP Control SetNC-505001NC-5050012016-07-08
00816057020645ASI EB VCA IgG EIA TestNC-880096-AGNC-880096-AG2016-07-08

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Primary DI, Brand, Company table
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