DEVICE: Acetylcholine Receptor Autoantibodies (ARAb) RRA (04049325001404)
Device Identifier (DI) Information
Acetylcholine Receptor Autoantibodies (ARAb) RRA
RE21021
In Commercial Distribution
RE21021
IBL International GmbH
RE21021
In Commercial Distribution
RE21021
IBL International GmbH
Acetylcholine Receptor Autoantibodies (ARAb) RRA Assay Kit - 100 determinations
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
Yes | |
Yes | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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62261 | 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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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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NST | Autoantibodies, Acetylcholine Receptor, Acetylcholine Blocking And Non-Blocking |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 2 and 8 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
3e12bdb0-290b-40e7-b204-8a87376eb6c7
March 29, 2018
2
September 24, 2016
March 29, 2018
2
September 24, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+49405328910
IBL@Tecan.com
IBL@Tecan.com