CD-Chex Plus BC 213377

GUDID 40844509000523

A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 5 vials of CD4L level.

STRECK, INC.

Multiple CD cell marker IVD, control Multiple CD cell marker IVD, control
Primary Device ID40844509000523
NIH Device Record Key4e86b61b-c009-4543-ba27-3138336a4d01
Commercial Distribution StatusIn Commercial Distribution
Brand NameCD-Chex Plus BC
Version Model Number213377
Catalog Number213377
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 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

Device Identifiers

Device Issuing AgencyDevice ID
GS140844509000523 [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 Date2016-09-16

On-Brand Devices [CD-Chex Plus BC]

00844509000549A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 5 vi
00844509000532A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 2 vi
40844509000523A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 5 via
40844509000516A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 5 vi
30844509000526A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 2 vi
30844509000519A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 2 vi
20844509000529A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 1 vi
20844509000512A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 1 vi

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