Eurotrol 250.001.002

GUDID 08718734960492

Assayed Quality control solution

Eurotrol B.V.

Total haemoglobin (totHb) IVD, control
Primary Device ID08718734960492
NIH Device Record Key34b3f589-4f4f-454f-890d-b0f516614cda
Commercial Distribution Discontinuation2016-08-27
Commercial Distribution StatusNot in Commercial Distribution
Brand NameEurotrol
Version Model Number250.001.002
Catalog Number250.001.002
Company DUNS412925992
Company NameEurotrol B.V.
Device Count2
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone9785983779
EmailofficeUSA@eurotrol.com
Phone9785983779
EmailofficeUSA@eurotrol.com
Phone9785983779
EmailofficeUSA@eurotrol.com
Phone9785983779
EmailofficeUSA@eurotrol.com
Phone9785983779
EmailofficeUSA@eurotrol.com
Phone9785983779
EmailofficeUSA@eurotrol.com
Phone9785983779
EmailofficeUSA@eurotrol.com
Phone9785983779
EmailofficeUSA@eurotrol.com
Phone9785983779
EmailofficeUSA@eurotrol.com
Phone9785983779
EmailofficeUSA@eurotrol.com
Phone9785983779
EmailofficeUSA@eurotrol.com
Phone9785983779
EmailofficeUSA@eurotrol.com
Phone9785983779
EmailofficeUSA@eurotrol.com
Phone9785983779
EmailofficeUSA@eurotrol.com
Phone9785983779
EmailofficeUSA@eurotrol.com
Phone9785983779
EmailofficeUSA@eurotrol.com

Operating and Storage Conditions

Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS108718734960492 [Primary]
GS108718734960508 [Unit of Use]

FDA Product Code

JPKMixture, Hematology Quality Control

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2025-01-28
Device Publish Date2016-08-26

On-Brand Devices [Eurotrol]

08718734960928Product is packaged in Eurotrol boxes, containing 5 ampules, one ampule of each level. It is a c
08718734960904179.003.010
08718734960881179.002.010
08718734960867179.001.010
08718734960539Assayed Quality control solution
08718734960515Assayed Quality control solution
08718734960492Assayed Quality control solution

Trademark Results [Eurotrol]

Mark Image

Registration | Serial
Company
Trademark
Application Date
EUROTROL
EUROTROL
79341935 not registered Live/Pending
Eurotrol B.V.
2022-04-25
EUROTROL
EUROTROL
77283386 3448423 Live/Registered
Eurotrol B.V.
2007-09-19

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.