BTNX Inc.

⚠️ High Risk

FEI: 3003917514 • Pickering, Ontario • CANADA

FEI

FEI Number

3003917514

📍

Location

Pickering, Ontario

🇨🇦

Country

CANADA

🏢

Address

722 Rosebank Rd, , Pickering, Ontario, Canada

High Risk

FDA Import Risk Assessment

65.9

LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

Total Refusals

Unique Violations

5/13/2024

Latest Refusal

11/1/2013

Earliest Refusal

Score Breakdown

Violation Severity

68.1×40%

Refusal Volume

65.9×30%

Recency

66.6×20%

Frequency

56.0×10%

How is this score calculated?

Proprietary Algorithm

40% Violation Severity — AI-assessed (1-10)
30% Refusal Volume — Logarithmic scale
20% Recency — Decays over 5 years
10% Frequency — Refusals per year

Violation Summary

50852×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

23715×

NO PMA

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).

1184×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

3414×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

32803×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

24801×

RXPERSONAL

The article appears to be a device which requires a prescription from your doctor.

Refusal History

Date	Product	Violations	Division
5/13/2024	83QKOREAGENT, CORONAVIRUS SEROLOGICAL	508NO 510(K)	Division of Southeast Imports (DSEI)
5/16/2023	83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES	508NO 510(K)	Division of Southeast Imports (DSEI)
3/17/2023	88OTURESEARCH USE ONLY/PATHOLOGY	508NO 510(K)	Division of Southeast Imports (DSEI)
3/9/2023	83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.	508NO 510(K)	Division of Southeast Imports (DSEI)
3/1/2023	83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.	508NO 510(K)	Division of Southeast Imports (DSEI)
1/13/2023	83QKOREAGENT, CORONAVIRUS SEROLOGICAL	237NO PMA 508NO 510(K)	Division of Southeast Imports (DSEI)
11/30/2022	83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.	508NO 510(K)	Division of Southeast Imports (DSEI)
11/1/2022	83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES	508NO 510(K)	Division of Southeast Imports (DSEI)
10/11/2022	83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.	118NOT LISTED 3280FRNMFGREG 341REGISTERED	Division of Southeast Imports (DSEI)
9/23/2022	83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES	118NOT LISTED 3280FRNMFGREG	Division of Southeast Imports (DSEI)
8/19/2022	83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES	237NO PMA 508NO 510(K)	Division of Southeast Imports (DSEI)
7/25/2022	83QMNCOVID-19 MULTI-ANALYTE ANTIGEN DEVICE	508NO 510(K)	Division of Southeast Imports (DSEI)
7/12/2022	83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.	237NO PMA 508NO 510(K)	Division of Southeast Imports (DSEI)
7/5/2022	83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES	508NO 510(K)	Division of Southeast Imports (DSEI)
6/30/2022	83QKOREAGENT, CORONAVIRUS SEROLOGICAL	508NO 510(K)	Division of Southeast Imports (DSEI)
6/2/2022	83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES	508NO 510(K)	Division of Southeast Imports (DSEI)
6/1/2022	83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.	237NO PMA 508NO 510(K)	Division of Southeast Imports (DSEI)
4/11/2022	83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.	237NO PMA 508NO 510(K)	Division of Southeast Imports (DSEI)
4/7/2022	83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID	237NO PMA 508NO 510(K)	Division of Southeast Imports (DSEI)
4/1/2022	83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.	508NO 510(K)	Division of Southeast Imports (DSEI)
3/31/2022	83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.	508NO 510(K)	Division of Southeast Imports (DSEI)
3/30/2022	83QKOREAGENT, CORONAVIRUS SEROLOGICAL	508NO 510(K)	Division of Southeast Imports (DSEI)
3/15/2022	83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES	508NO 510(K)	Division of Southeast Imports (DSEI)
3/10/2022	83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID	508NO 510(K)	Division of Southeast Imports (DSEI)
3/10/2022	83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.	508NO 510(K)	Division of Southeast Imports (DSEI)
3/8/2022	83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES	237NO PMA 508NO 510(K)	Division of Southeast Imports (DSEI)
3/4/2022	83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.	508NO 510(K)	Division of Southeast Imports (DSEI)
3/2/2022	83QKOREAGENT, CORONAVIRUS SEROLOGICAL	508NO 510(K)	Division of Southeast Imports (DSEI)
2/23/2022	83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.	508NO 510(K)	Division of Southeast Imports (DSEI)
2/22/2022	83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES	237NO PMA 508NO 510(K)	Division of Southeast Imports (DSEI)
2/22/2022	83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.	237NO PMA	Division of Southeast Imports (DSEI)
2/17/2022	83QMNCOVID-19 MULTI-ANALYTE ANTIGEN DEVICE	118NOT LISTED 237NO PMA 508NO 510(K)	Division of Southeast Imports (DSEI)
2/14/2022	83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES	508NO 510(K)	Division of Southeast Imports (DSEI)
2/9/2022	83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES	508NO 510(K)	Division of Southeast Imports (DSEI)
2/9/2022	83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES	508NO 510(K)	Division of Southeast Imports (DSEI)
2/9/2022	83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES	508NO 510(K)	Division of Southeast Imports (DSEI)
2/9/2022	83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES	508NO 510(K)	Division of Southeast Imports (DSEI)
2/9/2022	83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES	508NO 510(K)	Division of Southeast Imports (DSEI)
2/9/2022	83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.	237NO PMA 508NO 510(K)	Division of Southeast Imports (DSEI)
2/7/2022	83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES	508NO 510(K)	Division of Southeast Imports (DSEI)
2/7/2022	83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.	237NO PMA 508NO 510(K)	Division of Southeast Imports (DSEI)
1/28/2022	83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.	237NO PMA 508NO 510(K)	Division of Southeast Imports (DSEI)
1/27/2022	83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.	508NO 510(K)	Division of Southeast Imports (DSEI)
1/25/2022	83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID	237NO PMA 508NO 510(K)	Division of Southeast Imports (DSEI)
1/24/2022	83QKOREAGENT, CORONAVIRUS SEROLOGICAL	508NO 510(K)	Division of Southeast Imports (DSEI)
1/24/2022	83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID	237NO PMA 508NO 510(K)	Division of Southeast Imports (DSEI)
1/18/2022	83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.	508NO 510(K)	Division of Southeast Imports (DSEI)
1/13/2022	83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.	508NO 510(K)	Division of Southeast Imports (DSEI)
1/12/2022	83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID	508NO 510(K)	Division of Southeast Imports (DSEI)
1/12/2022	88PPMGENERAL PURPOSE REAGENT	508NO 510(K)	Division of Southeast Imports (DSEI)
1/7/2022	83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES	508NO 510(K)	Division of Southeast Imports (DSEI)
1/5/2022	75NUKANTIGEN, ANTI-CARDIAC, INDIRECT FLUORESCENT ANTIBODY TEST SYTEM	508NO 510(K)	Division of Southeast Imports (DSEI)
10/8/2021	83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.	508NO 510(K)	Division of Southeast Imports (DSEI)
7/29/2021	83QKOREAGENT, CORONAVIRUS SEROLOGICAL	118NOT LISTED 3280FRNMFGREG	Division of Southeast Imports (DSEI)
5/13/2020	83QKOREAGENT, CORONAVIRUS SEROLOGICAL	2480RXPERSONAL 508NO 510(K)	Division of Southeast Imports (DSEI)
4/28/2020	83QKOREAGENT, CORONAVIRUS SEROLOGICAL	508NO 510(K)	Division of Southeast Imports (DSEI)
12/20/2013	81KHEREAGENT, OCCULT BLOOD	341REGISTERED	New Orleans District Office (NOL-DO)
12/20/2013	75CGAGLUCOSE OXIDASE, GLUCOSE	341REGISTERED	New Orleans District Office (NOL-DO)
11/1/2013	81KHEREAGENT, OCCULT BLOOD	341REGISTERED	New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is BTNX Inc.'s FDA import refusal history?

BTNX Inc. (FEI: 3003917514) has 59 FDA import refusal record(s) in our database, spanning from 11/1/2013 to 5/13/2024.

What is an FEI number?

FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. BTNX Inc.'s FEI number is 3003917514.

What types of violations has BTNX Inc. received?

BTNX Inc. has been cited for 6 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.

Where does this information about BTNX Inc. come from?

All FDA import refusal data for BTNX Inc. is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.

Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.