DEVICE: CellaVision® Remote Review Software version 6.0.x, Annual license (07350040974506)

Device Identifier (DI) Information

CellaVision® Remote Review Software version 6.0.x, Annual license
CRRS-006001
In Commercial Distribution
CRRS-006001
Cellavision AB
07350040974506
GS1

1
508663101 *Terms of Use
The CellaVision remote review software enable remote users to access data collected, stored and processed by CellaVision DM Instruments with the ability to reclassify cells and sign off slides from another location.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
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
Laboratory instrument/analyser application software IVD A software program intended to be used with an in vitro diagnostic instrument/analyser (e.g., microscope slide digital imaging scanner, immunoassay analyser), or a data management device connected to the IVD instrument/analyser, to facilitate user-controlled device function and/or data processing, display, or communication (e.g., image conversion, incubation control).
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FDA Product Code

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Product Code Product Code Name
JOY Device, Automated Cell-Locating
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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

a936f7f9-4bfd-4b5a-868b-ad19ab264cc9
March 29, 2018
2
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

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
+46464601600
service@cellavision.se
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