FDA UDI
In Commercial Distribution
🇺🇸 United States
C4c control slides
DI: B502BSB30390
·
Model: Control Slides, 5
·
BIO SB, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- C4c control slides
- Primary DI
- B502BSB30390
- Version / Model
- Control Slides, 5
- Catalog Number
- BSB 3039
- Company Name
- BIO SB, INC.
- Labeler DUNS
- 102855447
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-06-30
- Public Version
- 2
- Public Version Date
- 2025-03-05
- Public Version Status
- Update
- Public Device Record Key
- b2ad3ca1-530c-44c0-9e17-1d0feb447f62
Device Description
C4c 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
- 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 |
|---|---|---|---|---|
| 31471 | Complement components C4/C4c IVD, control | A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of complement cascade components C4 and/or C4c in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B502BSB30390 | HIBCC |