Taiwan FDA registration 0e2528192c8a7bb2c7d2fa934ae88c6c

Cutting-edge all-in-one drug abuse rapid test reagent

TW: 尖端醫多合一藥物濫用快速檢驗試劑

Taiwan·Risk Class 2·Formosa Biomedical Technology Co., Ltd. Yilan Factory·Registered Oct 23, 2018 – Dec 06, 2022Cancelled

Registration details

Analysis ID: 0e2528192c8a7bb2c7d2fa934ae88c6c

Company information

Manufacturer: Formosa Biomedical Technology Co., Ltd. Yilan Factory
Manufacturer Country: Taiwan, Province of China
Authorized Representative: TAIWAN ADVANCE BIO-PHARMACEUTICAL INC.

Product details

Intended Use: This product is used by competitive immunochromatography to qualitatively detect morphine (MOP), amphetamine (AMP), methamphetamine (MET), ecstasy (MDMA), kaitamine (KET), cannabis (THC), cocaine (COC), benzodiazepines (nitropine OXA/flunazepam FM2/one capsule NTZ), spicy cannabis (K2) metabolites (JWH-018 and JWH-073) in human urine. The test results can be used as initial screening with morphine positive thresholds of 300 ng/ml, amphetamine positive threshold of 1000 ng/ml, methamphetamine positive threshold of 500 ng/ml, ecstasy positive threshold of 500 ng/ml, katamine positive threshold of 100 ng/ml, cannabis positive threshold of 50 ng/ml, cocaine positive threshold of 300 ng/ml, benzodiazepine positive threshold of 300 ng/ml, flunazepam 400 ng/ ml, one capsule 100 ng/ml, spicy cannabis metabolites (JWH-018 and JWH-073) positive threshold was 50 ng/ml. This product can be used by both individuals and professionals.
Product Type (Level 1): A Clinical chemistry and clinical toxicology
Product Type (Level 2): A.0001 苯環利定試驗系統
Import Information: Domestic;; Contract manufacturing

Dates and status

Registration Date: Oct 23, 2018
Expiry Date: Dec 06, 2022
Cancellation Date: Apr 12, 2024

Cancellation information

Status: Logged out
Reason: 許可證已逾有效期

About this record

Access comprehensive regulatory information for Cutting-edge all-in-one drug abuse rapid test reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 0e2528192c8a7bb2c7d2fa934ae88c6c and manufactured by Formosa Biomedical Technology Co., Ltd. Yilan Factory. The authorized representative in Taiwan is TAIWAN ADVANCE BIO-PHARMACEUTICAL INC..

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