DEVICE: Uricult® CLED+Polymyxin / MacConkey (06438115000006)

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Device Identifier (DI) Information

Uricult® CLED+Polymyxin / MacConkey
68017
1003
Orion Diagnostica Oy
06438115000006
GS1
10
A dip slide culture method for the detection of bacteriuria and the presumptive identification of uropathogens.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
Yes
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Urinary micororganism agar culture medium IVD, basic A non-selective and/or differential agar culture medium intended to be used for the growth and isolation of urinary tract microorganisms from a clinical specimen.
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FDA Product Code

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Product Code Product Code Name
JSI Culture Media, Selective And Differential
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Temperature: between 45 and 77 Degrees Fahrenheit
Storage Environment Temperature: between 7 and 25 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
May 13, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: 06438115001058 CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+358104261
product.support@oriondiagnostica.fi
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