STaK-Chex 225512

GUDID 00844509001188

A whole blood assayed hematology control that offers complete assay values for the 5-part white cell differential available with Beckman Coulter STKS™, MAXM™, HmX and LH 500. Contains 4 vials each of low, normal & high levels.

STRECK, INC.

Full blood count IVD, control
Primary Device ID00844509001188
NIH Device Record Key954a5459-a257-464a-afb2-3e8eaa9ee13b
Commercial Distribution StatusIn Commercial Distribution
Brand NameSTaK-Chex
Version Model Number225512
Catalog Number225512
Company DUNS072915986
Company NameSTRECK, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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 Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-228-6090
Emailcustserv@streck.com

Device Dimensions

Total Volume4 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100844509001188 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JCNControl, Cell Counter, Normal And Abnormal

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-19

On-Brand Devices [STaK-Chex]

00844509001188A whole blood assayed hematology control that offers complete assay values for the 5-part white
00844509001171A whole blood assayed hematology control that offers complete assay values for the 5-part white
30844509001158A whole blood assayed hematology control that offers complete assay values for the 5-part white
20844509001168A whole blood assayed hematology control that offers complete assay values for the 5-part white
20844509001151A whole blood assayed hematology control that offers complete assay values for the 5-part white
20844509001144A whole blood assayed hematology control that offers complete assay values for the 5-part white

Trademark Results [STaK-Chex]

Mark Image

Registration | Serial
Company
Trademark
Application Date
STAK-CHEX
STAK-CHEX
75623750 2335221 Live/Registered
STRECK, INC.
1999-01-19
STAK-CHEX
STAK-CHEX
74266212 1742704 Dead/Cancelled
STRECK LABORATORIES, INC.
1992-04-16

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