FDA UDI
In Commercial Distribution
🇺🇸 United States
PSAP Control Slides
DI: B502BSB59090
·
Model: Control Slides, 5
·
BIO SB, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PSAP Control Slides
- Primary DI
- B502BSB59090
- Version / Model
- Control Slides, 5
- Catalog Number
- BSB 5909
- Company Name
- BIO SB, INC.
- Labeler DUNS
- 102855447
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-08-31
- Public Version
- 1
- Public Version Date
- 2020-09-08
- Public Version Status
- New
- Public Device Record Key
- 32466856-0eff-43d2-9533-e7f522f7095b
Device Description
PSAP, 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 |
|---|---|---|---|---|
| 59643 | Metachromatic leukodystrophy 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 the inherited disorder metachromatic leukodystrophy, an inherited disorder associated with progressive destruction of the white matter of the nervous system due to mutation in the arylsulfatase A (ARSA) and prosaposin (PSAP) genes. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B502BSB59090 | HIBCC |