DEVICE: Affymetrix (00856826006050)

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Device Record History
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Device Identifier (DI) Information
Affymetrix
2.1
In Commercial Distribution
610533
Affymetrix, Inc.
00856826006050
GS1

1
804682573 *Terms of Use
No description.
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
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?
58047 Laboratory instrument application software IVD
An individual software program or group of programs, routines or algorithms that add specific data communication, display, processing and/or system integration capabilities to one or more pre-analytical laboratory processing functions (eg. robotic specimen transfer, aliquoting, pipetting, serial dilutions, reagent dispensing, etc) and assay processing functions (microplate washing, incubation control, plate agitation etc) using a series of programmable sequences and data communication facilities to achieve semi-automated throughput. The program applications are restricted to instrument operations and do not generally include data reduction, result interpretation or reporting facilities.
Obsolete false
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FDA Product Code

[?]
Product Code Product Code Name
NSU Instrumentation For Clinical Multiplex Test Systems
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
7306debe-e1d1-42ab-aa2f-f5e9cc9b9756
February 12, 2025
3
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
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

[?]
No
No
No
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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