FDA UDI
In Commercial Distribution
🇺🇸 United States
TdT Control Cell Suspension
DI: B7829500A07
·
Model: 9500A
·
Supertechs, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- TdT Control Cell Suspension
- Primary DI
- B7829500A07
- Version / Model
- 9500A
- Catalog Number
- 9500
- Company Name
- Supertechs, Inc.
- Labeler DUNS
- 071245690
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-10-08
- Public Version
- 3
- Public Version Date
- 2023-11-15
- Public Version Status
- Update
- Public Device Record Key
- 4e9f780d-d458-454c-a8bc-7735be7dd124
Device Description
Cell suspension containing fixed human lymphoblastoid REH (TdT+) and RA-1 (TdT-) cells 50% TdT+ and 50% TdT- cells at a concentration of 2 x 10^7 cells/mL 1.0 mL bottle for approximately 20 tests
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KIR | Cells, Animal And Human, Cultured | Hematology | 864.2280 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 54699 | Terminal deoxynucleotidyl transferase (TdT) IVD, control | A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of terminal deoxynucleotidyl transferase (TdT) in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B7829500A07 | HIBCC |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 4 – 4 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not freeze