Data / Medical devices / Canada / Citest Diagnostics Inc.
Citest Diagnostics Inc.: FDA-registered device maker in VANCOUVER British Columbia, Canada, 16 510(k) clearances
Citest Diagnostics Inc. is registered with the FDA (registration 3023296261) in VANCOUVER British Columbia, Canada. It lists 32 device types. The FDA files 16 510(k) clearances under its listings, the newest dated April 30, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3023296261
- Address
- Richards ST, VANCOUVER British Columbia, Canada, V6B 2Z4
- Owner or operator
- Citest Diagnostics Inc. (10090628)
- Roles
- Repackager or relabeler
- First device listed
- April 21, 2024
- Registered through
- 2027
- Brand names listed
- Citest Digital Early Pregnancy Home Test, Citest Digital Pregnancy Home Test, Citest Early Pregnancy Home Test, Citest Fentanyl Home Test, Citest Fentanyl Rapid Test, Citest Fentanyl Test, Citest Multi Drug Rapid Test Cup, Citest Multi Drug Rapid Test Panel and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 30, 2026 | K260342 | AllTest Strep A Rapid Test | GTY | Substantially Equivalent | Hangzhou AllTest Biotech Co., Ltd. | accessdata.fda.gov |
| October 30, 2025 | K252607 | AllTest Urinary Tract Infection Test | JMT | Substantially Equivalent | Hangzhou AllTest Biotech Co., Ltd. | accessdata.fda.gov |
| July 15, 2025 | K251053 | Shinetell PlusTM Digital Early Pregnancy Test | LCX | Substantially Equivalent | Hangzhou AllTest Biotech Co., Ltd. | accessdata.fda.gov |
| April 4, 2025 | K250727 | AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup | NFT | Substantially Equivalent | Hangzhou AllTest Biotech Co., Ltd. | accessdata.fda.gov |
| April 4, 2025 | K242576 | AllTest Viral Transport Medium | JSM | Substantially Equivalent | Hangzhou AllTest Biotech Co., Ltd. | accessdata.fda.gov |
| February 27, 2025 | K244043 | AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup | NFT | Substantially Equivalent | Hangzhou AllTest Biotech Co., Ltd. | accessdata.fda.gov |
| September 27, 2024 | K242540 | AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test Panel | NFT | Substantially Equivalent | Hangzhou AllTest Biotech Co., Ltd. | accessdata.fda.gov |
| August 13, 2024 | K241978 | Shinetell Digital Pregnancy Test | LCX | Substantially Equivalent | Hangzhou AllTest Biotech Co., Ltd. | accessdata.fda.gov |
| June 17, 2024 | K241428 | AllTest Multi-Drug Urine Test Cup ; AllTest Multi-Drug Rapid Urine Test Cup | NFT | Substantially Equivalent | Hangzhou AllTest Biotech Co., Ltd. | accessdata.fda.gov |
| April 5, 2024 | K234152 | ACESO Early Pregnancy Test | LCX | Substantially Equivalent | Aceso Laboratories, Inc. | accessdata.fda.gov |
| December 13, 2023 | K233019 | AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel Rx | DKZ | Substantially Equivalent | Hangzhou AllTest Biotech Co., Ltd. | accessdata.fda.gov |
| October 26, 2023 | K233417 | AllTest Fentanyl Urine Test Cassette | NGL | Substantially Equivalent | Hangzhou AllTest Biotech Co., Ltd. | accessdata.fda.gov |
| July 31, 2023 | K231698 | AllTest Fentanyl Rapid Test (Urine) | DJG | Substantially Equivalent | Hangzhou AllTest Biotech Co., Ltd. | accessdata.fda.gov |
| January 31, 2022 | K203272 | Alltest Pregnancy Rapid Combo Test Cassette | JHI | Substantially Equivalent | Hangzhou AllTest Biotech Co., Ltd. | accessdata.fda.gov |
| March 27, 2019 | K182738 | Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Multi-Drug Rapid Test Panel (Urine), Single and Multi-Drug Rapid Test Cup With Adulteration (Urine), Single and Multi-Drug Rapid Test Cup (Urine), Single Drug Rapid Test Dipstick (Urine), Single and Multi-Drug Home Rapid Test Panel (Urine), Single and Multi-Drug Home Rapid Test Cup (Urine), Single Drug Home Rapid Test Dipstick (Urine) | DKZ | Substantially Equivalent | Hangzhou AllTest Biotech Co., Ltd. | accessdata.fda.gov |
| May 18, 2018 | K180771 | Acro HCG Pregnancy Rapid Test | LCX | Substantially Equivalent | Acro Biotech, Inc. | accessdata.fda.gov |
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Updated April 30, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.