DEVICE: Acetylcholine Receptor Autoantibodies (ARAb) RRA (04049325001404)

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Device Identifier (DI) Information

Acetylcholine Receptor Autoantibodies (ARAb) RRA
RE21021
RE21021
IBL International GmbH
04049325001404
GS1
1
Acetylcholine Receptor Autoantibodies (ARAb) RRA Assay Kit - 100 determinations
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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
Acetylcholine receptor antibody IVD, kit, radioimmunoassay A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to acetylcholine receptor in a clinical specimen, using a radioimmunoassay method. It is typically used in the differential diagnosis of Myasthenia gravis (MG).
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FDA Product Code

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Product Code Product Code Name
NST Autoantibodies, Acetylcholine Receptor, Acetylcholine Blocking And Non-Blocking
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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 24, 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)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+49405328910
IBL@Tecan.com
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