Cell-Chex 212425

GUDID 00844509000297

Cell-Chex is a body fluid procedural control for red blood cell (RBC) and white blood cell (WBC) counts, crystal identification, and white blood cell differentiation. Contains 6 vials each of L1-UC and L2.

STRECK, INC.

Full blood count IVD, control
Primary Device ID00844509000297
NIH Device Record Key3b7f91d6-59d5-4518-abdd-fc29b9896597
Commercial Distribution StatusIn Commercial Distribution
Brand NameCell-Chex
Version Model Number212425
Catalog Number212425
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 Volume2 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100844509000297 [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 Date2016-09-16

On-Brand Devices [Cell-Chex]

00844509000303Cell-Chex is a body fluid procedural control for red blood cell (RBC) and white blood cell (WBC)
00844509000297Cell-Chex is a body fluid procedural control for red blood cell (RBC) and white blood cell (WBC)
00844509000280Cell-Chex is a body fluid procedural control for red blood cell (RBC) and white blood cell (WBC)
30844509000267Cell-Chex is a body fluid procedural control for red blood cell (RBC) and white blood cell (WBC)
20844509000277Cell-Chex is a body fluid procedural control for red blood cell (RBC) and white blood cell (WBC)
20844509000260Cell-Chex is a body fluid procedural control for red blood cell (RBC) and white blood cell (WBC)
20844509000253Cell-Chex is a body fluid procedural control for red blood cell (RBC) and white blood cell (WBC)

Trademark Results [Cell-Chex]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CELL-CHEX
CELL-CHEX
85410938 4166939 Live/Registered
Streck, Inc.
2011-08-30
CELL-CHEX
CELL-CHEX
78700736 not registered Dead/Abandoned
Streck Laboratories, Inc.
2005-08-25
CELL-CHEX
CELL-CHEX
77818922 not registered Dead/Abandoned
Streck, Inc.
2009-09-02
CELL-CHEX
CELL-CHEX
73024278 1027707 Dead/Expired
STRECK LABORATORIES, INC.
1974-06-14

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