DEVICE: ADAM-rWBC System (08809317540276)
Device Identifier (DI) Information
ADAM-rWBC System
ADAM-rWBC System
In Commercial Distribution
ADAM-rWBC System
NanoEnTek, Inc.
ADAM-rWBC System
In Commercial Distribution
ADAM-rWBC System
NanoEnTek, Inc.
ADAM-rWBC System is composted ADAM-rWBC(equipment) and ADAM-rWBC kit (reagent). This system is intended to be used for the qualitative determination of the residual white blood cell (leukocyte) count in human specimen.
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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55858 | White blood cell count IVD, kit, cell count |
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative determination of the white blood cell (leukocyte) count and/or the differential of white cell types in a clinical specimen using a manual, semi-automated or automated cell count method.
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FDA Product Code
[?]Product Code | Product Code Name |
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GKZ | Counter, Differential Cell |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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BK120015 | 0 |
BK120068 | 0 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
f646ecba-d06d-4196-8f6d-bcc3ec84e27f
July 23, 2024
5
September 30, 2016
July 23, 2024
5
September 30, 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
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
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No Customer Contact currently defined