ADAM

GUDID 08809317540993

The ADAM-rWBC HT residual leukocyte counter is a designed for counting residual white blood cells (rWBCs) in leukoreduced blood products.

NanoEnTek, Inc.

White blood cell count IVD, kit, cell count White blood cell count IVD, kit, cell count White blood cell count IVD, kit, cell count White blood cell count IVD, kit, cell count White blood cell count IVD, kit, cell count White blood cell count IVD, kit, cell count White blood cell count IVD, kit, cell count White blood cell count IVD, kit, cell count White blood cell count IVD, kit, cell count White blood cell count IVD, kit, cell count White blood cell count IVD, kit, cell count White blood cell count IVD, kit, cell count White blood cell count IVD, kit, cell count White blood cell count IVD, kit, cell count White blood cell count IVD, kit, cell count White blood cell count IVD, kit, cell count
Primary Device ID08809317540993
NIH Device Record Keyf06b1a17-e09d-41f3-b4dc-80bfa1fce13f
Commercial Distribution StatusIn Commercial Distribution
Brand NameADAM
Version Model NumberADAM-rWBC HT
Company DUNS687910463
Company NameNanoEnTek, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108809317540993 [Primary]
GS108809317540993 [Primary]
GS108809317540993 [Primary]
GS108809317540993 [Primary]
GS108809317540993 [Primary]
GS108809317540993 [Primary]
GS108809317540993 [Primary]
GS108809317540993 [Primary]
GS108809317540993 [Primary]
GS108809317540993 [Primary]
GS108809317540993 [Primary]
GS108809317540993 [Primary]
GS108809317540993 [Primary]
GS108809317540993 [Primary]
GS108809317540993 [Primary]
GS108809317540993 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GKZCounter, Differential Cell
GKZCounter, Differential Cell
GKZCounter, Differential Cell
GKZCounter, Differential Cell
GKZCounter, Differential Cell
GKZCounter, Differential Cell
GKZCounter, Differential Cell
GKZCounter, Differential Cell
GKZCounter, Differential Cell
GKZCounter, Differential Cell
GKZCounter, Differential Cell
GKZCounter, Differential Cell
GKZCounter, Differential Cell
GKZCounter, Differential Cell
GKZCounter, Differential Cell
GKZCounter, Differential Cell

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-23
Device Publish Date2021-02-15

On-Brand Devices [ADAM]

08809317540634ADAMII-CD34 Kit is designed for use with the ADAMII instrument, benchtop image-based fluorescenc
08809317540627ADAMII is a device to count stained CD series (e.g. CD34, CD3, CD4, CD8, CD45, etc.) in human sa
08809317541006It is used for the quantitative determination of the residual white blood cell (leukocyte) count
08809317540993The ADAM-rWBC HT residual leukocyte counter is a designed for counting residual white blood cell

Trademark Results [ADAM]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ADAM
ADAM
88920500 not registered Live/Pending
Adam Grooming Atelier Ltd.
2020-05-18
ADAM
ADAM
88512473 not registered Live/Pending
Contraline, Inc.
2019-07-12
ADAM
ADAM
88273579 not registered Live/Pending
FOOD Freshly AFC GmbH
2019-01-23
ADAM
ADAM
87879314 not registered Dead/Abandoned
Munich Holdings Ltd.
2018-04-16
ADAM
ADAM
87525805 not registered Live/Pending
ZOSANO PHARMA CORPORATION
2017-07-12
ADAM
ADAM
87392461 not registered Live/Pending
MosquitoMate, Inc.
2017-03-30
ADAM
ADAM
87356728 5296125 Live/Registered
LetsGoLearn, Inc.
2017-03-02
ADAM
ADAM
87246942 5489309 Live/Registered
AMADA MIYACHI AMERICA, INC.
2016-11-23
ADAM
ADAM
86956452 not registered Live/Pending
Popcorn Design LLC
2016-03-29
ADAM
ADAM
86875406 5263386 Live/Registered
Beston Technologies Pty Ltd
2016-01-14
ADAM
ADAM
86713897 5276944 Live/Registered
Schultz, Jacob
2015-08-04
ADAM
ADAM
86384917 4793321 Live/Registered
Drum Workshop, Inc.
2014-09-04

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