CD-Chex Plus 213323

GUDID 40844509000134

A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 1 vial of level Normal

STRECK, INC.

Multiple CD cell marker IVD, control Multiple CD cell marker IVD, control Multiple CD cell marker IVD, control Multiple CD cell marker IVD, control Multiple CD cell marker IVD, control Multiple CD cell marker IVD, control Multiple CD cell marker IVD, control Multiple CD cell marker IVD, control Multiple CD cell marker IVD, control Multiple CD cell marker IVD, control Multiple CD cell marker IVD, control Multiple CD cell marker IVD, control Multiple CD cell marker IVD, control Multiple CD cell marker IVD, control Multiple CD cell marker IVD, control Multiple CD cell marker IVD, control Multiple CD cell marker IVD, control Multiple CD cell marker IVD, control Multiple CD cell marker IVD, control
Primary Device ID40844509000134
NIH Device Record Key6605ba5b-17b8-467d-8844-c4838b037027
Commercial Distribution StatusIn Commercial Distribution
Brand NameCD-Chex Plus
Version Model Number213323
Catalog Number213323
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
Phone1-800-228-6090
Emailcustserv@streck.com
Phone1-800-228-6090
Emailcustserv@streck.com
Phone1-800-228-6090
Emailcustserv@streck.com
Phone1-800-228-6090
Emailcustserv@streck.com
Phone1-800-228-6090
Emailcustserv@streck.com
Phone1-800-228-6090
Emailcustserv@streck.com
Phone1-800-228-6090
Emailcustserv@streck.com
Phone1-800-228-6090
Emailcustserv@streck.com
Phone1-800-228-6090
Emailcustserv@streck.com
Phone1-800-228-6090
Emailcustserv@streck.com
Phone1-800-228-6090
Emailcustserv@streck.com
Phone1-800-228-6090
Emailcustserv@streck.com
Phone1-800-228-6090
Emailcustserv@streck.com
Phone1-800-228-6090
Emailcustserv@streck.com
Phone1-800-228-6090
Emailcustserv@streck.com
Phone1-800-228-6090
Emailcustserv@streck.com
Phone1-800-228-6090
Emailcustserv@streck.com

Device Dimensions

Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 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
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
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
GS140844509000134 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GGLControl, White-Cell

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 Date2016-12-01

On-Brand Devices [CD-Chex Plus]

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00844509000167A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 5 vi
00844509000150A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 2 vi
00844509000129A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 5 vi
00844509000112A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 2 vi
00844509000105A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 1 vi
40844509000141A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 1 vi
40844509000134A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 1 vi
40844509000080A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 8 vi
30844509000144A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 5 vi
30844509000137A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 5 vi
30844509000090A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 5 v
30844509000083A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 5 vi
20844509000147A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 2 vi
20844509000130A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 2 vi
20844509000093A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 2 vi
20844509000086A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 2 vi
10844509000096A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 1 v
10844509000089A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 1 vi

Trademark Results [CD-Chex Plus]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CD-CHEX PLUS
CD-CHEX PLUS
86112962 4779896 Live/Registered
Streck, Inc.
2013-11-07

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