DEVICE: BD FACSCanto™ (00382903394739)

Device Identifier (DI) Information

BD FACSCanto™
339473
In Commercial Distribution
339473
BECTON, DICKINSON AND COMPANY
00382903394739
GS1

1
024230633 *Terms of Use
BD FACSCanto II Cytometer IVD 5/3 System
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
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
Flow cytometry analyser IVD, automated A mains electricity (AC-powered) laboratory instrument intended to be used to count, examine and/or sort cells or microscopic particles in a clinical specimen (e.g., blood, urine). Detection of individual components is performed using an optical or electrical detection system based on physical or chemical characteristics, or by detecting immunological markers introduced to the sample during the preanalytical phase and bound via antigen-antibody reactions. The device operates with minimal technician involvement and complete automation of all procedural steps.
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FDA Product Code

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Product Code Product Code Name
OYE Flow cytometric reagents and accessories.
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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

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

cb78eadd-b8d6-40b6-aa16-257057d0c490
March 29, 2018
2
June 08, 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

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
+1(877)232-8995
BDBCustomerService@bd.com
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