FDA UDI
In Commercial Distribution
🇺🇸 United States
Cell-Free DNA BCT
DI: 10844509002250
·
Model: 230469
·
STRECK, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
6
Basic Information
- Brand Name
- Cell-Free DNA BCT
- Primary DI
- 10844509002250
- Version / Model
- 230469
- Catalog Number
- 230469
- Company Name
- STRECK, INC.
- Labeler DUNS
- 072915986
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 6
- Record Status
- Published
- Publish Date
- 2020-08-10
- Public Version
- 2
- Public Version Date
- 2021-11-10
- Public Version Status
- Update
- Public Device Record Key
- 15f91e98-6445-4e87-8090-509cb7c0cd6d
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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QMA | Blood Collection Device For Cell-Free Nucleic Acid | Clinical Chemistry | 862.1676 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63121 | Evacuated blood collection tube IVD, anticoagulant/nucleic acid stabilizer | A 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00844509002253 | GS1 | ||||
| Primary | 10844509002250 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| DEN200001 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 10 | Milliliter |