Cell-Free DNA BCT

Primary DI
00844509002253
Brand
Cell-Free DNA BCT
Company
STRECK, INC.
Model
230471
Catalog number
230471
Device description
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.
Published
2020-08-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
QMABlood Collection Device For Cell-Free Nucleic Acid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QMABlood Collection Device For Cell-Free Nucleic AcidClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN200001000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN200001000Cell-Free DNA BCTStreck, Inc.2020-08-07QMA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10844509002250PrimaryGS10
20844509002257PrimaryGS10
30844509002254PrimaryGS10
00844509002253Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084450900225010844509002250
2084450900225720844509002257
3084450900225430844509002254
00844509002253008445090022538445090022530844509002253

GMDN Terms#

Term, Definition table
TermDefinition
Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizerA sterile glass or plastic tube, sealed with a stopper, containing a pre-measured amount of vacuum, an anticoagulant agent [e.g., tripotassium ethylene diamine tetraacetic acid (K3EDTA)], and a nucleic acid (DNA/RNA) stabilizer. It is intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume10Milliliter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
072915986
Device count
1000
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20844509000314Cal-Chex A Plus 2211062211062016-09-16
30844509000311Cal-Chex A Plus 2211072211072016-09-16
40844509000318Cal-Chex A Plus2211082211082016-09-16
20844509000338STaK-Chex Plus Retics2254812254812016-09-19
00844509001379CVA2915042915042016-09-16
00844509001386CVA2917082917082016-09-16
00844509001393CVA2917092917092016-09-16
00844509001409CVA2917102917102016-09-16
00844509001416CVA2917112917112016-09-16
00844509001423CVA2917122917122016-09-16
00844509001430CVA2917132917132016-09-16
00844509001447CVA2917142917142016-09-16
00844509001560CVA for CellDyn 2917152917152016-09-16
00844509001577CVA for CellDyn 2917182917182016-09-16
00844509001584CVA for CellDyn 2917192917192016-09-16
00844509001591CVA for CellDyn 2917202917202016-09-16
00844509001669CVA2917222917222016-09-16
20844509000246Cal-Chex2211012211012016-09-16
30844509000243Cal-Chex 2211032211032016-09-16
10844509000089CD-Chex Plus2133252133252016-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10844509002250Cell-Free DNA BCTSTRECK, INC.QMA2020-08-10
20844509002257Cell-Free DNA BCTSTRECK, INC.QMA2020-08-10
30844509002254Cell-Free DNA BCTSTRECK, INC.QMA2020-08-10