HemoTrol WB 08718734960942

GUDID 08718734960973

HemoTrol® WB is an assayed quality control material for professional use to verify the performance characteristics of the HemoCue ® Hb 301 and the HemoCue ® Hb 801 System. HemoTrol® WB is intended for the quantitative determination of hemoglobin.

Eurotrol B.V.

Total haemoglobin (totHb) IVD, control
Primary Device ID08718734960973
NIH Device Record Key9ce4b258-9126-4a3d-a3b3-4104633b5edd
Commercial Distribution Discontinuation2024-08-28
Commercial Distribution StatusNot in Commercial Distribution
Brand NameHemoTrol WB
Version Model NumberLow
Catalog Number08718734960942
Company DUNS412925992
Company NameEurotrol B.V.
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 Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108718734960942 [Package]
Package: Box [2 Units]
Discontinued: 2024-08-28
Not in Commercial Distribution
GS108718734960973 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GGMControl, Hemoglobin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2024-08-29
Device Publish Date2019-03-18

On-Brand Devices [HemoTrol WB]

08718734960966HemoTrol® WB is an assayed quality control material for professional use to verify the performa
08718734960959HemoTrol® WB is an assayed quality control material for professional use to verify the performa
08718734960973HemoTrol® WB is an assayed quality control material for professional use to verify the performa

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