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Sign in to claim this brandAmeritek, Inc.
US
Last updated May 30, 2026
What Ameritek, Inc. makes
Ameritek, Inc. manufactures rapid diagnostic tests, including immunochromatographic kits for detecting human chorionic gonadotropin (beta-HCG) in urine and serum, as well as drug screening test kits for substances like tetrahydrocannabinol, cocaine, and amphetamines. The company also produces reagent strips for urinalysis, home-use urinary tract infection test kits, and occult blood test kits. Additionally, it supplies ophthalmic medical devices such as an electrically controlled intravenous pole and a surgical intraocular pressure (IOP) monitor, alongside a vacuum fixation ring system for surgical applications.
Ameritek’s products are regulated under the FDA’s Class I and Class II device classifications, with many cleared via the 510(k) pathway and listed under the Unique Device Identifier (UDI) system. The company’s devices are primarily intended for in vitro diagnostics, surgical aids, and drug testing, adhering to U.S. regulatory standards for medical devices.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- ameritek.org
- —
- —
- [email protected]
- Phone
- 4253792580
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 943032649
Catalogue (18)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| dBest | N/A | FDA UDI | Class II | Active |
| Dbest One-Step Hcg Serum/Urine Test | K973957 | FDA 510(k) | Class II | Active |
| Dbest Tetrahydrocannabinol Test Kit | K983188 | FDA 510(k) | Class II | Active |
| Surgical Iop Monitor | K863235 | FDA 510(k) | Class II | Active |
| Rk Vacuum Fixation Ring System | K863775 | FDA 510(k) | Class I | Active |
| Dbest Reagent Strip For Urinalysis | K973142 | FDA 510(k) | Class II | Active |
| Dbset Multidrug Screen Test Kit | K990681 | FDA 510(k) | Class II | Active |
| Electrically Controlled I.v. Pole (opthalmic) | K861013 | FDA 510(k) | Class I | Active |
| Dbest Cocaine Test Kit | K983191 | FDA 510(k) | Class II | Active |
| Dbest Urinary Tract Infection Test Kit For Home-Use | K990873 | FDA 510(k) | Class I | Active |
| Dbest Occult Blood Test Kit | K984269 | FDA 510(k) | Class II | Active |
| Dbest Amphetamines Test Kit | K981504 | FDA 510(k) | Class II | Active |
| Dbest Methamphetamines Test Kit | K983189 | FDA 510(k) | Class II | Active |
| Best Pregnancy Test | K953606 | FDA 510(k) | Class II | Active |
| Dbest Opiates Test Kit | K983190 | FDA 510(k) | Class II | Active |
| Dbest Hcg 2 Iu/Ml Test Kit | K001215 | FDA 510(k) | Class II | Active |
| Rare Earth Intra-Ocular Magnet | K860960 | FDA 510(k) | Class I | Active |
| Dbest One-Step Ovulation Test | K974508 | FDA 510(k) | Class I | Active |
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