DEVICE: ADAM-rWBC System (08809317540276)

Device Identifier (DI) Information

ADAM-rWBC System
ADAM-rWBC System
In Commercial Distribution
ADAM-rWBC System
NanoEnTek, Inc.
08809317540276
GS1

1
687910463 *Terms of Use
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.
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Device Characteristics

Labeling does not contain MRI Safety Information
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GMDN

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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?
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

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Product Code Product Code Name
GKZ Counter, Differential Cell
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
BK120015 0
BK120068 0
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Sterilization

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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

f646ecba-d06d-4196-8f6d-bcc3ec84e27f
July 23, 2024
5
September 30, 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
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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

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Customer Contact

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No Customer Contact currently defined
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