FDA UDI
In Commercial Distribution
🇺🇸 United States
PMS2 Control Slides
DI: B502BSB2373CS0
·
Model: Control Slides, 5
·
BIO SB, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PMS2 Control Slides
- Primary DI
- B502BSB2373CS0
- Version / Model
- Control Slides, 5
- Catalog Number
- BSB-2373-CS
- Company Name
- BIO SB, INC.
- Labeler DUNS
- 102855447
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-10-30
- Public Version
- 1
- Public Version Date
- 2020-11-09
- Public Version Status
- New
- Public Device Record Key
- b94926e5-9dec-4951-ab75-2054e676474e
Device Description
PMS2-control
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
- Yes
- 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 |
|---|---|---|---|---|
| 59539 | Hereditary nonpolyposis colon cancer (HNPCC) IVD, control | A material which is used to verify the performance of an assay intended to be used to evaluate a clinical specimen to diagnose, monitor or predict hereditary nonpolyposis colon cancer (HNPCC) associated with mutations in one of several genes that are important in the detection and repair of deoxyribonucleic acid (DNA) base-pair mismatches which may include MLH1, MSH2, MLH3, MSH6, PMS1 and PMS2. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B502BSB2373CS0 | HIBCC |