FDA.reportPublic FDA data

Alere™ PBP2a SA Culture Colony Test

Primary DI
10811877010842
Brand
Alere™ PBP2a SA Culture Colony Test
Company
Alere Scarborough, Inc.
Model
893-000
Device description
A rapid test for the qualitative detection of PBP2a in Staphylococcus aureus isolates.
Published
2016-09-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
K133851000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133851000ALERE PBP2A SA/CONS CULTURE COLONY TESTAlere Scarborough, Inc.2014-09-03MYI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10811877010842PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081187701084210811877010842

GMDN Terms#

Term, Definition table
TermDefinition
Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, kitA collection of reagents and other associated materials intended to be used to determine the identification and antimicrobial susceptibility profile of bacterial species isolated from a clinical specimen by culture.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
154148498
Device count
1
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10811877010064ISOSTAT® Consumables50C92016-09-05
00811877012214BinaxNOW COVID-19/Flu A&B Combo Self Test200023502026-05-06
00811877012221BinaxNOW COVID-19/Flu A&B Combo Self Test200023512026-05-06
10811877011245WOUNDCHEK™ Bacterial Status360006US2020-05-26
00811877012153ID NOW InstrumentNAT-024R2025-08-01
00811877011477BinaxNOW COVID-19 Antigen Self Test195-1402023-09-05
00811877011118BinaxNOW COVID-19 Antigen Self Test195-1702023-08-11
00811877011729BinaxNOW COVID-19 Antigen Self Test195-1802022-10-03
00811877011408BinaxNOW COVID-19 Antigen Self Test195-1602021-04-21
10811877010934Osteomark NTx Urine90062020-09-16
10811877010941Osteomark NTx Serum90212020-09-16
00811877010050ISOSTAT® Press and Rack50C22016-09-05
00811877010098ISOSTAT® Containment Adapter50C12016-09-03
00811877012030BinaxNOW COVID-19/Flu A&B Combo Self Test20002050 2025-01-30
00811877012047BinaxNOW COVID-19/Flu A&B Combo Self Test20002056 2025-01-30
00811877012054BinaxNOW COVID-19/Flu A&B Combo Self Test200020512025-01-30
00811877012061BinaxNOW COVID-19/Flu A&B Combo Self Test20002057 2025-01-30
00811877012078BinaxNOW COVID-19/Flu A&B Combo Self Test20002052 2025-01-30
00811877012085BinaxNOW COVID-19/Flu A&B Combo Self Test20002058 2025-01-30
00811877012092BinaxNOW COVID-19/Flu A&B 20002054 2025-01-30

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
00816576021840NAHARDY DIAGNOSTICSMYI2016-09-23