High Technology, Inc.
Registration 3013660430FEI 3013660430North Attleboro, MA
Owner/operator: High Technology, Inc.
- Manufacture Device in the United States for Export Only
- Manufacture Medical Device
- Repack or Relabel Medical Device
Renewal due by December 31, 2026
Registered through 2026. Renew between October 1 and December 31, 2026, to stay registered for 2027.
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The 2026 window
- Oct 1Window opens91 days left
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- FDA fee, FY2027
- $13,785
- Our pay-by suggestion
- Dec 1
- Listed devices
- 64
- Added, last 12 months
- 0
FDA sets who pays the fee and who may qualify for a waiver; its fee page says so. The fee is paid only on FDA’s own fee site. Never through us. FDA’s fee page
The steps, in order
Pay FDA's annual feeYou
Order and pay the FY2027 establishment fee on FDA's Device Facility User Fee site. FDA emails you a PIN when you order.
FDA: registration and listing payment processWait for the payment confirmation numberYou
FDA emails a Payment Confirmation Number (PCN) once the payment processes, which FDA says typically takes several days. That is why we suggest paying by December 1.
FDA: registration and listing payment processRenew the registration in FDA's systemYou
Sign in to FDA's Unified Registration and Listing System (FURLS), complete the annual registration and apply your PIN and PCN. FDA does not count the registration as complete until both are applied.
FDA: device registration and listingReview every listingYou
In the same window, review each listing on file and report any changes, deletions and new listings. Your Listing Review Sheet puts every listing on one page.
FDA: device registration and listing
Every listed device 64
| Code | Device | Class | Regulation | Premarket |
|---|---|---|---|---|
| JFH | Acid Phosphatase Reagent SetAcid Phosphatase (Prostatic), Tartrate Inhibited | Class 2 | 21 CFR 862.1020 | — |
| GFO | HT-Coag APTT Reagent kitActivated Partial Thromboplastin | Class 2 | 21 CFR 864.7925 | — |
| DDZ | Microalbumin Reagent SetAlbumin, Fitc, Antigen, Antiserum, Control | Class 2 | 21 CFR 866.5040 | — |
| DIC | Alcohol Reagent SetAlcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method | Class 2 | 21 CFR 862.3040 | — |
| LCP | Fructosamine Reagent SetAssay, Glycosylated Hemoglobin | Class 2 | 21 CFR 864.7470 | — |
| CEK | Microprotein Reagent SetBiuret (Colorimetric), Total Protein | Class 2 | 21 CFR 862.1635 | — |
| CIX | Albumin Reagent SetBromcresol Green Dye-Binding, Albumin | Class 2 | 21 CFR 862.1035 | — |
| JIX | Chemistry Multi-Calibrator SetCalibrator, Multi-Analyte Mixture | Class 2 | 21 CFR 862.1150 | — |
| JIS | Direct HDL/LDL Control SetCalibrator, Primary | Class 2 | 21 CFR 862.1150 | — |
| JIT | Microalbumin Calibrator SetCalibrator, Secondary | Class 2 | 21 CFR 862.1150 | — |
| GKL | MicroCC-20 PlusCounter, Cell, Automated (Particle Counter) | Class 2 | 21 CFR 864.5200 | — |
| CIC | Calcium Arsenazo Reagent SetCresolphthalein Complexone, Calcium | Class 2 | 21 CFR 862.1145 | — |
and 52 more on your full dossier
What changed
Nothing added in the last twelve months, and no change seen on the record yet.