Select

Primary DI
03610521536215
Brand
Select
Company
BIO-RAD
Model
63763
Device description
MRSASelectTM II - 100 tests
Published
2018-02-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JSOCulture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JSOCulture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton AgarMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171061000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171061000MRSASelect IIBio-Rad2017-12-28JSO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03610521536215PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03610521536215036105215362153610521536215

GMDN Terms#

Term, Definition table
TermDefinition
MRSA agar culture medium IVD, chromogenicA selective and/or differential agar culture medium containing chromogenic substrates intended to be used to screen for the presence of methicillin-resistant Staphylococcus aureus (MRSA) microorganisms 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

Contacts#

Phone, Email table
PhoneEmail
1-800-224-6723techsupport.ussd-redmond@bio-rad.com

Regulatory Flags#

DUNS number
269902602
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03610522220526Platelia12015253120152532023-07-03
03610520002933Select63747637472016-08-16
03610520007860PLATELIA25296252962016-08-16
03610520007877PLATELIA25297252972016-08-16
03610522220519Platelia12015289120152892023-07-03
03610520010785GEENIUS92465924652023-02-03
03610520013328EVOLIS89601896012023-02-03
03610520013571PR 410091587915872023-02-03
03610520014103BIO-RAD87530875302023-02-03
03610522189380Platelia12014064120140642023-01-08
03610520002940Select63748637482023-01-05
03610520034309Select63740637402023-01-05
03610520000953Pastorex56353563532022-12-22
03610520000960Pastorex56356563562022-12-22
03610520002490Platelia62786627862022-12-22
03610520002902Select63726637262022-12-22
03610520002919Select63727637272022-12-22
03610520002971Select63751637512016-08-16
03610520007853PLATELIA26211262112016-08-16
03610520013847Geenius 72461724612015-01-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10382902154218BD BBL™ CHROMagar™ MRSA II / CHROMagar™ SABECTON, DICKINSON AND COMPANYJSO2024-08-22
30382902154212BD BBL™ CHROMagar™ MRSA II / CHROMagar™ SABECTON, DICKINSON AND COMPANYJSO2024-08-22
00816576026845HardyCHROM™HARDY DIAGNOSTICSJSO2023-12-08
00816576026838HardyCHROM™HARDY DIAGNOSTICSJSO2023-12-08
00848838085628SPECTRAREMEL, INC.JSO2022-12-22
00848838085635SPECTRAREMEL, INC.JSO2022-12-22
00816576026807HardyCHROMHARDY DIAGNOSTICSJSO2020-05-20
00816576025770HardyCHROM™HARDY DIAGNOSTICSJSO2019-10-21
03573026597719CHROMID® CARBA agarBIOMERIEUX SAJSO2018-09-28
03573026409913CHROMID® CARBA agarBIOMERIEUX SAJSO2018-09-28
03610521536208SelectBIO-RADJSO2018-02-09
00816576023097HardyCHROM™HARDY DIAGNOSTICSJSO2017-03-28
10382902152283BD BBL™ CHROMagar® MRSA IIBECTON, DICKINSON AND COMPANYJSO2016-12-23
30382902152287BD BBL™ CHROMagar® MRSA IIBECTON, DICKINSON AND COMPANYJSO2016-12-23
10382902152290BD BBL™ CHROMagar® MRSA IIBECTON, DICKINSON AND COMPANYJSO2016-12-21
10382902212406BD BBL™ GC II Agar with IsoVitaleX™ EnrichmentBECTON, DICKINSON AND COMPANYJSO2016-12-21
10382902219542BD BBL™ Haemophilus Test Medium Agar (HTM Agar)BECTON, DICKINSON AND COMPANYJSO2016-12-21
30382902212400BD BBL™ GC II Agar with IsoVitaleX™ EnrichmentBECTON, DICKINSON AND COMPANYJSO2016-12-21
30382902152294BD BBL™ CHROMagar® MRSA IIBECTON, DICKINSON AND COMPANYJSO2016-12-21
30382902219546BD BBL™ Haemophilus Test Medium Agar (HTM Agar)BECTON, DICKINSON AND COMPANYJSO2016-12-21
10382902153594BD BBL™ CHROMagar™ MRSA II / CHROMagar™ SABECTON, DICKINSON AND COMPANYJSO2016-12-16
30382902153598BD BBL™ CHROMagar™ MRSA II / CHROMagar™ SABECTON, DICKINSON AND COMPANYJSO2016-12-16
00848838004216NAREMEL, INC.JSO2016-12-09
05032384002924NAOXOID LIMITEDJSO2016-09-24
05032384003150NAOXOID LIMITEDJSO2016-09-24
05032384003174NAOXOID LIMITEDJSO2016-09-24
05032384003181NAOXOID LIMITEDJSO2016-09-24
05032384003198NAOXOID LIMITEDJSO2016-09-24
00848838000522NAREMEL, INC.JSO2016-09-24
00848838000546NAREMEL, INC.JSO2016-09-24