NA

Primary DI
00816576021840
Brand
NA
Company
HARDY DIAGNOSTICS
Model
DR900A
Catalog number
DR900A
Device description
MRSA-Screen consists of latex reagent sensitized with a monoclonal antibody against penici lin—binding protein 2'(2a). or PBP2' (PBP2a), together with control latex and 2'extraction reagents to rapidly extract PBP2' from the bacterial cell membranes of MRSA. Extracts are prepared by boiling a suspension of S. aureus cells under alkaline conditions, followed by neutralization and a centrifugation step. The supernatant is subsequently mixed with the latexreagents on a test card and visible clumping or agglutination within three minutes with the sensitized latex but not the control latex confirms the presence of MRSA.MATERIALS SUPPLIEDSensitized Test Latex - (dropper bottle with pink cap) Latex particles are sensitized with a monoclonal antibody against PBP2'.Control Latex - (dropper bottle with a blue cap) Latex particles are sensitized with a monoclonal antibody of the same IgG subclass but against a human protein showing no reactivity with proteins of Staphylococcus aureus .Extraction Reagent 1 - (green cap) 0.1 mol/L NaOHExtraction Reagent 2 - (yellow cap) 0.5 mol/L KH 2 PO 4Test CardsMixing SticksPackage Insert
Published
2016-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MYISystem,Test,Genotypic Detection,Resistant Markers,Staphylococcus Colonies

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MYISystem, Test, Genotypic Detection, Resistant Markers, Staphylococcus ColoniesMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K011400000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K011400000MRSA-SCREENDenka Seiken'S2002-03-27MYI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816576021840PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816576021840008165760218408165760218400816576021840

GMDN Terms#

Term, Definition table
TermDefinition
Staphylococcus aureus culture isolate antigen IVD, kit, agglutinationA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from Staphylococcus aureus bacteria isolated by culture from a clinical specimen, using an agglutination method.

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
800-266-2222techservice@hardydiagnostics.com

Regulatory Flags#

DUNS number
039981550
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10811877011238Clearview PBP2a SA Culture Colony TestAlere Scarborough, Inc.MYI2020-01-20
15060392372705MASTALEX-MRSAMAST GROUP LIMITEDMYI2018-05-02
00812125010082mecA XpressFISH®ADVANDX, INC.MYI2016-11-08
05032384096442NAOXOID LIMITEDMYI2016-09-24
10811877010842Alere™ PBP2a SA Culture Colony Test Alere Scarborough, Inc.MYI2016-09-01