DEVICE: Dako (05700572028383)

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Device Identifier (DI) Information

Dako
FR700

Dako Denmark A/S
05700572028383
GS1
1
Monoclonal Mouse Anti-Human CD45/FITC, Clone T29/33 Monoclonal Mouse Anti-Human CD14/RPE, Clone TÜK4
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Device Characteristics

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

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
CD45 leukocyte common antigen cell marker IVD, antibody One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of CD45 leukocyte common antigen cell marker in a clinical specimen.
CD14 cell marker IVD, antibody One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of CD14 cell marker in a clinical specimen.
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FDA Product Code

[?]
Product Code Product Code Name
GKZ Counter, differential cell
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Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius
Special Storage Condition, Specify: Keep away from sunlight
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Clinically Relevant Size

[?]
Size Type Text
Total Volume: 0.5 Milliliter
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Device Status

In Commercial Distribution
September 16, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
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

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

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+4544859500
dako.dkregulatory@agilent.com
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