FDA · United States
technetium tc-99m red blood cell kit — FDA regulatory status
technetium tc-99m red blood cell kit (ULTRATAG) regulatory status in the United States is tracked from public FDA records and cross-linked clinical and patent datasets on NovaPharmaNews. Current status: FDA approved.
Status snapshot
- Status
- FDA approved
- Brand
- ULTRATAG
- Mechanism
- Diagnostic agent
- Structured fields
- 5
Pharmacology context used for competitive intelligence: Diagnostic agent. This page is a status aggregation for professional reference — not prescribing advice.
Regional decision snapshot — FDA: approved.
Linked evidence on this spoke: 10 published clinical programs and 0 related patent records. Use the tables below for NCT identifiers, phases, and exclusivity dates; verify against primary sources before BD or medical decisions.
Regulatory timeline
| Regulator | Region | Status | Date | Source |
|---|---|---|---|---|
| FDA | United States | approved | — | Evidence |
Linked clinical programs
| Program | Phase | Sponsor | NCT |
|---|---|---|---|
| RBC transfusion based on different protocols | Phase 3 | Chinese Academy of | NCT02139995 |
| Blood test | Phase 2 | Yang Xiaotian | NCT06454071 |
| Blood Glucose Meter Systems | Approved | Universal Integrated | NCT02789319 |
| Blood draw for Lp(a) | Unknown | Novartis India | NCT03887520 |
| Blood ponction | Unknown | MAIA Biotechnology | NCT06304129 |
| Blood sample | Unknown | Ultragenyx UK | NCT03810859 |
| blood draw from three different vessels | Unknown | Sionna Therapeutics | NCT03096561 |
| blood sampling | Unknown | ME Therapeutics | NCT06738511 |
| blood sampling | Unknown | ME Therapeutics | NCT06703632 |
| blood sampling (alpha-Galactosidase & LysoGb3) | Unknown | Takeda | NCT04943991 |
Related hubs
FAQ
What is the FDA approval status of technetium tc-99m red blood cell kit?
technetium tc-99m red blood cell kit currently shows FDA approved in our United States regulatory index. Confirm on the official FDA label or EPAR before clinical or commercial use.
Where does NovaPharmaNews get technetium tc-99m red blood cell kit regulatory data?
Status fields are joined from public sources (openFDA / EMA / regional agencies), ClinicalTrials.gov-linked programs, and patent registries. See /about/data-sources for attribution.
How many clinical programs are linked to technetium tc-99m red blood cell kit?
This spoke lists 10 published programs associated with technetium tc-99m red blood cell kit in our pipeline index.