ADAM-rWBC System ADAM-rWBC System

GUDID 08809317540276

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.

NanoEnTek, Inc.

White blood cell count IVD, kit, cell count
Primary Device ID08809317540276
NIH Device Record Keyf646ecba-d06d-4196-8f6d-bcc3ec84e27f
Commercial Distribution StatusIn Commercial Distribution
Brand NameADAM-rWBC System
Version Model NumberADAM-rWBC System
Catalog NumberADAM-rWBC System
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
GS108809317540276 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GKZCounter, Differential Cell

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2024-07-23
Device Publish Date2016-09-30

Devices Manufactured by NanoEnTek, Inc.

08809317540252 - ADAM-rWBC2024-07-23 ADAM-rWBC is a device to count white blood cell. It is used with ADAM-rWBC kit.
08809317540269 - ADAM-rWBC Kit2024-07-23 It is used for the quantitative determination of the residual white blood cell (leukocyte) count in a human specimen using ADAM-
08809317540276 - ADAM-rWBC System2024-07-23ADAM-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.
08809317540276 - ADAM-rWBC System2024-07-23 ADAM-rWBC System is composted ADAM-rWBC(equipment) and ADAM-rWBC kit (reagent). This system is intended to be used for the quali
08809317540498 - ADAM-rWBC22024-07-23 ADAM-rWBC2 is a device to count white blood cell. It is used with ADAM-rWBC Kit.
08809317540504 - ADAM-rWBC2 System2024-07-23 ADAM-rWBC2 System is composted ADAM-rWBC2(equipment) and ADAM-rWBC Kit (reagent). This system is intended to be used for the qua
08809317540016 - FREND TSH2024-07-22 It is used for the quantitative determination of Thyroid Stimulating Hormone in human specimen using FREND System.
08809317540191 - FREND Free T42024-07-22 It is used for the quantitative determination of free thyroxine(free t4) in human specimen using FREND System.
08809317540337 - FREND Vitamin D2024-07-22 It is used for the quantitative measurement of 25-hydroxy vitamin D and related hydroxylated metabolites in humna serum and plas
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