STaK-Chex Plus Retics 225483

GUDID 30844509000335

A 5-part differential control that monitors all parameters, including reticulocytes and nucleated red blood cells. Contains 12 vials of normal level.

STRECK, INC.

Full blood count IVD, control
Primary Device ID30844509000335
NIH Device Record Key00f33b30-d0fc-497a-8e8f-30204eadfa48
Commercial Distribution StatusIn Commercial Distribution
Brand NameSTaK-Chex Plus Retics
Version Model Number225483
Catalog Number225483
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
GS130844509000335 [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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