Identity
- Trade Name
- TdT Control Cell Suspension FDA UDI
- Generic Name
- Terminal deoxynucleotidyl transferase (TdT) IVD, control FDA UDI
- Device Name
- 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 FDA UDI
- Model / Reference
- 9500A FDA UDI
- 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 FDA UDI
Identifiers
- Catalog Number
- 9500 FDA UDI
- Primary DI / UDI-DI
- B7829500A07 FDA UDI
- FDA Product Code
- KIR FDA UDI
- GMDN Term
- Terminal deoxynucleotidyl transferase (TdT) IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.2280 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Terminal deoxynucleotidyl transferase (TdT) IVD, control
TdT Control Cell Suspension by Supertechs, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Supertechs, Inc.
Sources (1)
- FDA UDI 4e9f780d-d458-454c-a8bc-7735be7dd124 35 fields · synced Jun 1, 2026