Cyto-Chex BCT 230305

GUDID 20844509002202

A direct-draw blood collection tube for the preservation of whole blood specimens for immunophenotyping by flow cytometry. 4 ml vials.

STRECK, INC.

Evacuated blood collection tube IVD, K3EDTA Evacuated blood collection tube IVD, K3EDTA
Primary Device ID20844509002202
NIH Device Record Key6c91a7be-4895-4aa2-952e-f67accdf0312
Commercial Distribution StatusIn Commercial Distribution
Brand NameCyto-Chex BCT
Version Model Number230305
Catalog Number230305
Company DUNS072915986
Company NameSTRECK, INC.
Device Count25
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
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 Milliliter
Total Volume4 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100844509002208 [Unit of Use]
GS120844509002202 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GIMTubes, Vacuum Sample, With Anticoagulant

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

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 [Cyto-Chex BCT]

40844509002206A direct-draw blood collection tube for the preservation of whole blood specimens for immunophen
30844509002209A direct-draw blood collection tube for the preservation of whole blood specimens for immunophen
30844509000823A direct-draw blood collection tube for the preservation of whole blood specimens for immunophen
20844509002202A direct-draw blood collection tube for the preservation of whole blood specimens for immunophen
20844509000833A direct-draw blood collection tube for the preservation of whole blood specimens for immunophen
20844509000826A direct-draw blood collection tube for the preservation of whole blood specimens for immunophen

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