FDA UDI
In Commercial Distribution
🇺🇸 United States
BRAF V600E control slides
DI: B502BSB28300
·
Model: Control Slides, 5
·
BIO SB, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- BRAF V600E control slides
- Primary DI
- B502BSB28300
- Version / Model
- Control Slides, 5
- Catalog Number
- BSB 2830
- Company Name
- BIO SB, INC.
- Labeler DUNS
- 102855447
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-06-01
- Public Version
- 2
- Public Version Date
- 2025-03-05
- Public Version Status
- Update
- Public Device Record Key
- bb70612f-ac29-4d3a-a8b0-901535d46f6a
Device Description
BRAF V600E Control slides
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LJG | Quality Control Slides | Microbiology | 866.2660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58277 | BRAF V600 gene mutation IVD, control | A material which is used to verify the performance of an assay that is intended to be used to select treatment options and/or monitor the response to cancer therapy by determining the V600 mutation status of the BRAF (v-raf murine sarcoma viral oncogene homolog B1) gene e.g., (V600A, V600D, V600E, V600K and V600R) in tumour tissue. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B502BSB28300 | HIBCC |