STaK-Chex Plus Retics 225480

GUDID 20844509000321

A 5-part differential control that monitors all parameters, including reticulocytes and nucleated red blood cells. Contains 4 vials of low level.

STRECK, INC.

Full blood count IVD, control Full blood count IVD, control
Primary Device ID20844509000321
NIH Device Record Key31006649-eefb-4535-b4bc-156a18b641c9
Commercial Distribution StatusIn Commercial Distribution
Brand NameSTaK-Chex Plus Retics
Version Model Number225480
Catalog Number225480
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
Phone1-800-228-6090
Emailcustserv@streck.com

Device Dimensions

Total Volume4.5 Milliliter
Total Volume4.5 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS120844509000321 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GLQMixture, Control, White-Cell And Red-Cell Indices

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 Plus Retics]

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30844509000335A 5-part differential control that monitors all parameters, including reticulocytes and nucleate
20844509000345A 5-part differential control that monitors all parameters, including reticulocytes and nucleate
20844509000338A 5-part differential control that monitors all parameters, including reticulocytes and nucleate
20844509000321A 5-part differential control that monitors all parameters, including reticulocytes and nucleate

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