DEVICE: ImmunoCAP Total IgE Calibrator Strip (07333066011653)

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Device Identifier (DI) Information

ImmunoCAP Total IgE Calibrator Strip
34-2274-81
34-2274-81
Phadia AB
07333066011653
GS1
1
ImmunoCAP Total IgE Calibrator Strip
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
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
Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA) A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total immunoglobulin E (IgE total) in a clinical specimen, using an enzyme immunoassay (EIA) method.
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FDA Product Code

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Product Code Product Code Name
DGC IGE, ANTIGEN, ANTISERUM, CONTROL
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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 2 and 8 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
September 23, 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
07333066000367 5 07333066011653 In Commercial Distribution
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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: 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

[?]
+469999999999
xx@xx.xx
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