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 Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer| Primary Device ID | 00844509002253 |
| NIH Device Record Key | f889dcb3-08ce-491c-970c-3c1339473d3d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cell-Free DNA BCT |
| Version Model Number | 230471 |
| Catalog Number | 230471 |
| Company DUNS | 072915986 |
| Company Name | STRECK, INC. |
| Device Count | 1000 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Device Dimensions
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00844509002253 [Unit of Use] |
| GS1 | 10844509002250 [Primary] |
| GS1 | 20844509002257 [Primary] |
| GS1 | 30844509002254 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- deNovo: DEN200001
FDA Product Code
| QMA | Blood Collection Device For Cell-Free Nucleic Acid |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-08-18 |
| Device Publish Date | 2020-08-10 |
Devices Manufactured by STRECK, INC.
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| 00844509002376 - Streck Viral Extraction Kit | 2023-06-21 The Streck® Viral Extraction Kit is intended for use in isolating intact virus particles and associated viral nucleic acids (RN |
| 00844509002338 - MDx-Chex for BCID2 | 2022-02-02 MDx-Chex for BCID2 is intended for use as an external positive and negative assayed control to monitor the performance of the qu |
| 30844509000199 - Para 12® Plus | 2020-09-01 Para 12® Plus is an assayed hematology control for evaluating the accuracy and precision of hematology instruments that provide |
| 00844509002253 - Cell-Free DNA BCT | 2020-08-18Cell-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. |
| 00844509002253 - Cell-Free DNA BCT | 2020-08-18 Cell-Free DNA BCT is a direct-draw venous whole blood collection device intended for the collection, stabilization, and transpor |
Trademark Results [Cell-Free DNA BCT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CELL-FREE DNA BCT 85785470 4450121 Live/Registered |
Streck, Inc. 2012-11-21 |
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