Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test Dipcard
Co-Innovation Biotech Co., Ltd.
CO-INNOVATION BIOTECH CO.,LTD.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3010220539 | 3010220539 | CO-INNOVATION BIOTECH CO.,LTD. | 1 | N | 2026-01-01 | No. 9 Baihe 3 street, Economic and Technological Development Eas Guangzhou Guangdong CN 510530 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 151209 | 1087637581 | K241100 | Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test Dipcard | NGL | 2024-05-22 |
| 151209 | 1456192259 | K232732 | Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, Rapid Marijuana (THC) Test Strip 50, Rapid Marijuana (THC) Test Dipcard 50 | LDJ | 2024-01-17 |
| 151209 | 1330162875 | K231904 | Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard | DJG | 2024-03-08 |
| 151209 | 1155245585 | K213808 | Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Strip, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Cassette, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Midstream | LCX | 2022-04-05 |
| 151209 | 1324479684 | K153050 | Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard | DJG | 2016-04-26 |
| 151209 | 1940424815 | K142800 | Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard | DKZ | 2014-12-11 |
| 151209 | 1940403737 | K140748 | ONE STEP SINGLE/MULTI-DRUG TEST CUP, ONE STEP SINGLE/MULTI-DRUG TEST DIPCARD | DJG | 2014-08-20 |
| 151209 | 1341290895 | K140215 | ONE STEP SINGLE/MULTI-DRUG TEST CUP/DIPCARD | DIS | 2014-06-16 |
| 151209 | 1862319519 | K132085 | ONE STEP HCG TEST STRIP, ONE STEP HCG TEST CASSETTE, ONE STEP HCG TEST MIDSTREAM | LCX | 2013-11-12 |
| 151209 | 1893053090 | K131110 | ONE STEP SINGLE/MULTI-DRUG TEST CUP; ONE STEP SINGLE SINGLE/MULTI-DRUG TEST DIPCARD | DKZ | 2014-01-15 |
| 151209 | 1002879362 | ||||
| 151209 | 1023464166 | ||||
| 151209 | 1524872097 | ||||
| 151209 | 1147842302 | ||||
| 151209 | 1322208800 | ||||
| 151209 | 1586299382 | ||||
| 151209 | 2018312284 |
Product Codes Associated With Registrations#
PMN#
Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard
Co-Innovation Biotech Co., Ltd.
Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, Rapid Marijuana (THC) Test Strip 50, Rapid Marijuana (THC) Test Dipcard 50
Co-Innovation Biotech Co., Ltd.
Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Strip, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Cassette, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Midstream
Co-Innovation Biotech Co., Ltd.
Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard
Co-Innovation Biotech Co., Ltd
Rapid Single/Multi-drug Test Cup And Rapid Single/Multi-drug Test Dipcard
Co-Innovation Biotech Co., Ltd.
ONE STEP SINGLE/MULTI-DRUG TEST CUP, ONE STEP SINGLE/MULTI-DRUG TEST DIPCARD
CO-INNOVATION BIOTECH CO.,LTD.
ONE STEP SINGLE/MULTI-DRUG TEST CUP/DIPCARD
CO-INNOVATION BIOTECH CO., LTD.
ONE STEP SINGLE/MULTI-DRUG TEST CUP; ONE STEP SINGLE SINGLE/MULTI-DRUG TEST DIPCARD
CO-INNOVATION BIOTECH CO., LTD.
ONE STEP HCG TEST STRIP, ONE STEP HCG TEST CASSETTE, ONE STEP HCG TEST MIDSTREAM
CO-INNOVATION BIOTECH CO., LTD.
GUDID#
co-innovation - HCG TEST
2023-04-28
Flo - Flo PREGNANCY TEST STRIP
2026-03-31
Flo - Flo OVULATION TEST STRIP
2026-03-31
co-innovation - LH TEST
2025-10-20
co-innovation - COT TEST
2025-05-19
co-innovation - COT TEST
2025-05-19
co-innovation - FYL TEST
2024-08-20
co-innovation - FYL TEST
2024-08-20
DTPM - 13P
2023-12-08
DTPM - 16P
2023-12-08
DTPM - 13P
2023-12-08
DTPM - 16P
2023-12-08
Co-innovation - HCG Strip/4.0mm
2017-03-23
MomMed - HCG TEST STRIP
2018-12-31
AICARE - HCG Pregnancy Test Strip
2019-03-18
HealthyWiser - HCG Test Strip
2016-10-31
HCG TEST STRIP - HCG3.5
2019-12-25
PREGABLE - HCG TEST
2021-06-02
Co-innovation - HCG Cassette
2017-03-23
HCG TEST STRIP - HCG3.5
2019-12-25
co-innovation - HCG TEST
2023-04-28
co-innovation - Rapid Multi drug Test Cup 11 Pannel
2018-12-27
co-innovation - 12P Rapid Multi-Drug Test Cup
2017-04-07
co-innovation - 12P DRUG TEST DIPCARD
2018-06-08
co-innovation - 12P Drug Test Dipcard
2018-08-29
co-innovation - 12P drug test cup
2019-03-22
co-innovation - 14P Rapid Multi-Drug Test Cup
2017-06-19
co-innovation - 14P Drug Test
2022-01-15
co-innovation - 15P Drug Test
2022-01-15
co-innovation - 16P CUP
2021-03-29
co-innovation - 16P Drug Test
2022-01-15
co-innovation - 17P Drug Test
2022-01-15
co-innovation - 18P Drug Test
2022-01-15
co-innovation - Rapid Multi-drug Test Cup
2022-11-11
11Pannel drug test cup
2019-10-28
CIBIO Test - 12P Rapid Multi-Drug Test Cup
2016-10-27
CIBIO Test - 13P Rapid Multi-Drug Test Cup
2016-10-27
co-innovation - 14P DRUG TEST CUP
2018-10-08
Co-innovation - THC Strip/3.0mm
2017-03-23
co-innovation - Rapid THC Test Dipcard
2017-04-06