DEVICE: DxH (15099590798215)
Device Identifier (DI) Information
DxH
D20332
In Commercial Distribution
D20332
Beckman Coulter, Inc.
D20332
In Commercial Distribution
D20332
Beckman Coulter, Inc.
Beckman Coulter DxH Slides are 25 x 75 x 1 mm glass microscope slides with white or painted frosted ends, used with the DxH Slidemaker Stainers, fully automated slide preparation and staining device that smears a blood film on a slide, and delivers a variety of fixatives, stains, buffers, and rinse solutions to the blood smear on the slide.
Beckman Coulter DxH Slides are intended to be used to prepare whole blood samples for histological stains and preservation of blood for microscopic evaluation.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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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57925 | General specimen microscopy slide IVD, single-use |
A glass or plastic microscopy slide intended to be used for the collection, and preservation and/or transport, of any type of clinical specimen or smear for analysis and/or other investigation. This is a single-use device.
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FDA Product Code
[?]Product Code | Product Code Name |
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LXG | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use |
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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Handling Environment Temperature: between 15 and 30 Degrees Celsius |
Special Storage Condition, Specify: Keep Dry |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
3ac0bf13-c43e-4be4-824b-4f2c9d681b5e
April 14, 2025
1
April 04, 2025
April 14, 2025
1
April 04, 2025
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:
05099590798218
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined