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Sign in to claim this brandNuclear Diagnostics, Inc.
US
Last updated May 23, 2026
What Nuclear Diagnostics, Inc. makes
Nuclear Diagnostics, Inc. manufactures in vitro diagnostic test kits and radioimmunoassay kits, including the STIKSEP-T4 RIA KIT, SERUM THYROTROPIN ASSAY KIT, NUCLIPASE (I125) PANCREATIC LIPASE, and other thyroid and pancreatic function tests. Their products also include enzyme immunoassays, radioassays, and quality control materials like the TRI-LEVEL NDI CONTROL.
The company's devices are classified as Class I and Class II and are listed in the FDA 510(k) registry. Nuclear Diagnostics, Inc. is based in the US.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What does Nuclear Diagnostics, Inc. manufacture?
Nuclear Diagnostics, Inc. manufactures in vitro diagnostic test kits and radioimmunoassay kits, including thyroid and pancreatic function tests, enzyme immunoassays, radioassays, and quality control materials.
Where is Nuclear Diagnostics, Inc. based?
Nuclear Diagnostics, Inc. is based in the United States, as indicated by the country information provided in the device data.
Which regulatory registries list Nuclear Diagnostics, Inc.'s devices?
Nuclear Diagnostics, Inc.'s devices are listed in the FDA 510(k) registry, which is the only registry mentioned in the provided device data.
How are Nuclear Diagnostics, Inc.'s devices classified?
Nuclear Diagnostics, Inc.'s devices are classified as Class I and Class II, which are medical device classifications that determine the level of regulatory control required.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
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Catalogue (27)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Technologist Choice | TOR-23BT | FDA UDI | Class I | Active |
| Saturo | URC-120Y | FDA UDI | Class I | Active |
| Stiksep-T4 Ria Kit | K780423 | FDA 510(k) | Class II | Active |
| Serum Thyrotropin Assay Kit, Tipsep- | K833713 | FDA 510(k) | Class II | Active |
| Nuclipase (i125) Pancreatic Lipase | K823860 | FDA 510(k) | Class I | Active |
| Hermes Hd Aq Acquisition Station And Hermes Workstation | K002782 | FDA 510(k) | Class II | Active |
| Bio Nuclear Diagnostics (endo)cervical Sampler For Gyn Cytology | K081522 | FDA 510(k) | Class II | Active |
| Stiksep-T3 Kit | K780486 | FDA 510(k) | Class II | Active |
| Radioassay For Total Serum Thyroxine | K780644 | FDA 510(k) | Class II | Active |
| Tipsep-Tbg Assay | K861735 | FDA 510(k) | Class II | Active |
| Elipase Human Pancreatic Lipase Enzymeimmunoassay | K923917 | FDA 510(k) | Class I | Active |
| Tipsep Digoxin Ria | K852291 | FDA 510(k) | Class II | Active |
| Tri-Level Ndi Control | K810906 | FDA 510(k) | Class I | Active |
| Tipsep-T3u Triiodothyronine Uptake | K792484 | FDA 510(k) | Class II | Active |
| Nucli-Pap Tm-(i125)-Pap Radioimmunoas- | K802886 | FDA 510(k) | Class II | Active |
| Nuclitryp(tm)(i125)-Human Pancrea Cath Try Rad Kit | K932406 | FDA 510(k) | Class I | Active |
| Nuclear Laser Alignment System For Cardic Stress | K860472 | FDA 510(k) | Class I | Active |
| Tipsep-Cortisol Ria Diagnostic Kit | K872177 | FDA 510(k) | Class II | Active |
| Spinsep-T3 | K771854 | FDA 510(k) | Class II | Active |
| Ria Diag. Test Kit For Indexing Thyrox. | K781560 | FDA 510(k) | Class II | Active |
| Hermes Hdaq Acquisition Station And Hermes Workstation, Ver. 3.4 | K021656 | FDA 510(k) | Class II | Active |
| Tria-Peg Ria Diag. Kit | K780292 | FDA 510(k) | Class II | Active |
| Spinsep-Fe59 | K790133 | FDA 510(k) | Class I | Active |
| Tsh-P.e.g. | K811558 | FDA 510(k) | Class II | Active |
| Enzlipase, Enzymatic Lipase Kit | K862312 | FDA 510(k) | Class I | Active |
| Spinsep-Tbg | K771341 | FDA 510(k) | Class II | Active |
| Tipsep-T4(ria) T4 Radioimmunoassay | K792599 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Bio Nuclear Diagnostics, Inc. TORONTO Ontario · CA FEI 3005892511