ASI ASO Slide Test

Primary DI
00816057020157
Brand
ASI ASO Slide Test
Company
ARLINGTON SCIENTIFIC, INC.
Model
NC-300050E
Catalog number
NC-300050E
Device description
Detection of Anti-Streptolysin-O, Export
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
GTOAnti-Streptokinase

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GTOAnti-StreptokinaseMicrobiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K853857000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K853857000V-TREND ASO PLUS LATEX TESTTexas Immunology, Inc.1985-10-16GTQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816057020157PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816057020157008160570201578160570201570816057020157

GMDN Terms#

Term, Definition table
TermDefinition
Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of antibodies to streptolysin O enzyme produced by Group A beta-haemolytic Streptococcus bacteria in a clinical specimen.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
785966607
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

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00816057021697ASI RPR Automated Control Set NC-905002.5ANC-905002.5A2023-12-19
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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
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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816057020126ASI ASO Slide TestARLINGTON SCIENTIFIC, INC.GTO2016-07-08
00816057020133ASI ASO Slide TestARLINGTON SCIENTIFIC, INC.GTO2016-07-08
00816057020140ASI ASO Slide TestARLINGTON SCIENTIFIC, INC.GTO2016-07-08
00816057020164ASI ASO Slide TestARLINGTON SCIENTIFIC, INC.GTO2016-07-08
00816057020171ASI ASO Slide TestARLINGTON SCIENTIFIC, INC.GTO2016-07-08
00816057020188ASI ASO Slide TestARLINGTON SCIENTIFIC, INC.GTO2016-07-08
00816057021178ASI Disposable Stirrer PipetARLINGTON SCIENTIFIC, INC.GTO2016-07-08
00816057021185ASI Disposible Stirrer PipetARLINGTON SCIENTIFIC, INC.GTO2016-07-08
00816057021598ASI ASO Control SetARLINGTON SCIENTIFIC, INC.GTO2016-07-08