FDA UDI
In Commercial Distribution
🇺🇸 United States
Plastic Staining Dish
DI: B502BSB70090
·
Model: BSB 7009
·
BIO SB, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Plastic Staining Dish
- Primary DI
- B502BSB70090
- Version / Model
- BSB 7009
- Catalog Number
- BSB 7009
- Company Name
- BIO SB, INC.
- Labeler DUNS
- 102855447
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-03-18
- Public Version
- 1
- Public Version Date
- 2025-03-26
- Public Version Status
- New
- Public Device Record Key
- abd0306c-a32d-4c9d-a0be-37726e14e916
Device Description
Accessory of the Tinto Stainer Plus Automated System
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
- Labeling does not contain MRI Safety Information
- 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 |
|---|---|---|---|---|
| LXG | EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE | Clinical Chemistry | 862.2050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63042 | Assay container IVD, reusable | A reservoir (e.g., bottle, tube, cup) intended to be used to contain volumes of reagent, buffers, biological specimens, or other materials in preparation for in vitro diagnostic testing procedures performed in the laboratory. It is typically made of plastic or glass and may be used on the benchtop for manual procedures (e.g., rinsing of paraffin embedded tissues), or on-board automated liquid handling instruments or analysers. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B502BSB70090 | HIBCC |
Customer Contacts
- Phone
- +1(800)561-1145
- [email protected]