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FDA drafts guidance on ctDNA
Earlier this year, the U.S. Food and Drug Administration released a draft guidance regarding the use of circulating tumor DNA (ctDNA) for early-stage …
Read More Cell-Free DNA BCT®
For In Vitro Diagnostic Use
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.
Performance characteristics of this device have only been established on the Guardant360® CDx assay.
Product 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.
Cold chain free – Transport samples at room temperature
Citations
Resources
Instructions (IFU)
Product Information
Certificates
- Cell-Free DNA BCT IVD CoA Lot 1341 2023-03-13
- Cell-Free DNA BCT IVD CoA Lot 1360 2023-03-20
- Cell-Free DNA BCT IVD CoA Lot 2010 2023-03-27
- Cell-Free DNA BCT IVD CoA Lot 2017 2023-04-11
- Cell-Free DNA BCT IVD CoA Lot 2027 2023-04-18
- Cell-Free DNA BCT IVD CoA Lot 2062 2023-05-01
- Cell-Free DNA BCT IVD CoA Lot 2070 2023-05-08
- Cell-Free DNA BCT IVD CoA Lot 2081 2023-06-06
- Cell-Free DNA BCT IVD CoA Lot 2125 2023-06-27
- Cell-Free DNA BCT IVD CoA Lot 2158 2023-08-14
- Cell-Free DNA BCT IVD CoA Lot 2172 2023-08-28
- Cell-Free DNA BCT IVD CoA Lot 2182 2023-09-14
- Cell-Free DNA BCT IVD CoA Lot 2224 2023-10-04
- Cell-Free DNA BCT IVD CoA Lot 2270 2023-10-25
- Cell-Free DNA BCT IVD CoA Lot 2278 2023-11-09
- Cell-Free DNA BCT IVD CoA Lot 2311 2024-01-11
- Cell-Free DNA BCT IVD CoA Lot 2340 2024-02-15
- Cell-Free DNA BCT IVD CoA Lot 2347 2024-02-22
- Cell-Free DNA BCT IVD CoA Lot 3009 2024-03-19
- Cell-Free DNA BCT IVD CoA Lot 3051 2024-04-17
- Cell-Free DNA BCT IVD CoA Lot 3056 2024-05-07
- Cell-Free DNA BCT IVD CoA Lot 3076 2024-06-22
Looking for an older document? Click here for archived assays and certificates.
Ordering Information
| Description | Catalog Number |
|---|---|
| 10.0 mL tube – 16 x 100 mm | |
| 6-tube pack glass | 230469 |
| 100-tube box glass | 230470 |
| 1000-tube case glass | 230471 |
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Stabilization Products
Streck’s patented portfolio of stabilization solutions enables scientists to mitigate and limit pre-analytical variation in critical samples, ease handling concerns and allow for room temperature storage, cold chain-free shipping and batch processing. Our direct draw blood collection tubes and preservation products for biofluids are recognized worldwide. Target analytes include cell-free DNA, cell-free RNA, clusters of differentiation antigens, extracellular vesicles and cellular nucleic acids.
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