Cell-Free DNA BCT 230471

GUDID 00844509002253

Cell-Free DNA BCT is a direct-draw venous whole blood collection device intended for the collection, stabilization, and transport of venous whole blood samples for use in conjunction with cell-free DNA next- generation sequencing liquid biopsy assays that have been cleared or approved for use with samples collected in the Cell-Free DNA BCT device.

STRECK, INC.

Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer
Primary Device ID00844509002253
NIH Device Record Keyf889dcb3-08ce-491c-970c-3c1339473d3d
Commercial Distribution StatusIn Commercial Distribution
Brand NameCell-Free DNA BCT
Version Model Number230471
Catalog Number230471
Company DUNS072915986
Company NameSTRECK, INC.
Device Count1000
DM Exemptfalse
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
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Device Identifiers

Device Issuing AgencyDevice ID
GS100844509002253 [Unit of Use]
GS110844509002250 [Primary]
GS120844509002257 [Primary]
GS130844509002254 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QMABlood Collection Device For Cell-Free Nucleic Acid

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-08-18
Device Publish Date2020-08-10

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00844509002253 - Cell-Free DNA BCT2020-08-18Cell-Free DNA BCT is a direct-draw venous whole blood collection device intended for the collection, stabilization, and transport of venous whole blood samples for use in conjunction with cell-free DNA next- generation sequencing liquid biopsy assays that have been cleared or approved for use with samples collected in the Cell-Free DNA BCT device.
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Trademark Results [Cell-Free DNA BCT]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CELL-FREE DNA BCT
CELL-FREE DNA BCT
85785470 4450121 Live/Registered
Streck, Inc.
2012-11-21
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