DEVICE: REAADS Coagulation Control 1 (00855360006243)

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Device Identifier (DI) Information

REAADS Coagulation Control 1
701-001
701-001
CORGENIX MEDICAL CORPORATION
00855360006243
GS1
1
REAADS Coagulation Control 1 (CC-1) is an assayed control plasma in coagulation studies for In Vitro Diagnostic Use. PRINCIPLE OF THE PROCEDURE Coagulation Control 1 is tested in the same manner as citrated patient plasma samples to assess the performance of each assay run, for the parameters. Testing variables in each laboratory, including equipment, reagents, and technique may influence control recovery. Although an expected range is provided for each parameter, laboratories should establish their own expected range for their particular instrument-reagent system. Refer to Package Insert.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
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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
Multiple coagulation factor IVD, control A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative determination of one or multiple coagulation factors, coagulation intermediates and/or their activated components in a clinical specimen.
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FDA Product Code

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Product Code Product Code Name
GIZ Plasma, Control, Normal
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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
July 14, 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: No Unit of Use DI Numbers Found 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

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1-800-729-5661
technicalsupport@corgenix.com
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