FDA.reportPublic FDA data

Uricult CLED/EMB

Primary DI
06438115000037
Brand
Uricult CLED/EMB
Company
Aidian Oy
Model
68014
Catalog number
1000
Device description
A dip slide culture method for the detection of bacteriuria and the presumptive identification of uropathogens.
Published
2016-05-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JSHCulture Media, Non-Selective And Differential

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JSHCulture Media, Non-Selective And DifferentialMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06438115000037PrimaryGS10
06438115001041Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06438115000037064381150000376438115000037
06438115001041064381150010416438115001041

GMDN Terms#

Term, Definition table
TermDefinition
Multiple formulation agar culture medium IVDA combination of two or more selective, differential and/or enriched agar culture media formulations separately contained within a single petri dish (commonly referred to as a split plate) or dip slide and intended to be used for the simultaneous growth, selective isolation and/or differentiation of microorganisms from a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature7 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature45 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+358103093000product.support@oriondiagnostica.fi
+358103093000product.support@aidian.eu

Regulatory Flags#

DUNS number
401656868
Device count
10
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06438115000099QuikRead go® CRP1452151452152016-06-01
06438115000105QuikRead go® CRP Verification set1452161452162016-06-01
06438115000112QuikRead go® CRP Control set1452171452172016-06-01
06438115000198QuikRead go® Instrument1452181452182016-06-01
06438115000006Uricult® CLED+Polymyxin / MacConkey6801710032016-05-13
06438115000013Uricult® CLED+Polymyxin /EMB6801810022016-05-13
06438115000020Uricult® CLED/MacConkey6801910012016-05-13
06438115000044Uricult® Trio68197681972016-05-12
06438115000082UniQ® PINP RIA67034670342016-04-13

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