Cell-Chex Auto 200065

GUDID 00844509000587

Spinal and body fluid control for evaluating the accuracy and precision of hematology instruments that measure blood cell counts in patient body fluid samples. Contains 1 vial each of level 2 & 3.

STRECK, INC.

Full blood count IVD, control
Primary Device ID00844509000587
NIH Device Record Key42bba79f-a0fe-4fc0-8a14-034f08b0856e
Commercial Distribution StatusIn Commercial Distribution
Brand NameCell-Chex Auto
Version Model Number200065
Catalog Number200065
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 Volume3 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100844509000587 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Number3
Public Version Date2018-07-06
Device Publish Date2016-09-16

On-Brand Devices [Cell-Chex Auto]

00844509000600Spinal and body fluid control for evaluating the accuracy and precision of hematology instrument
00844509000594Spinal and body fluid control for evaluating the accuracy and precision of hematology instrument
00844509000587Spinal and body fluid control for evaluating the accuracy and precision of hematology instrument
20844509000574Spinal and body fluid control for evaluating the accuracy and precision of hematology instrument
20844509000567Spinal and body fluid control for evaluating the accuracy and precision of hematology instrument
20844509000550Spinal and body fluid control for evaluating the accuracy and precision of hematology instrument

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