Panels › Clinical Toxicology › Product code DIS · Class 2
Enzyme Immunoassay, Barbiturate
Regulation 862.3150
0510(k)s in 12 months (100 all time)
0recalls in 12 months (7 all time)
4recalls that name a 510(k)
Top companies in DIS
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 12, 2019 | Beckman Coulter Inc. SYNCHRON Systems Barbiturates Reagent (BARB 1 X 250); Catalog No. 475012 - Product Usage: BARB reagent, in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON Systems Drugs of Abuse Testing (DA Terminated |
DIS | K944075 |
| May 18, 2018 | Guangzhou Wondfo Biotech Co., Ltd. TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO, BARGO, SUPS, BZ030, COC20,MDMAlOO, METSO, OPl40,OXY20,THC2S)
Product Usage:
T-Cube One Step Multi-Drug Oral Fluid Test Cube is a rapid oral flu Open, Classified |
DIS | None listed |
| May 18, 2018 | Guangzhou Wondfo Biotech Co., Ltd. TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO, BARGO, BZ030,COC20,MDMA100,METSO, MTD30,OPl40,OXY20, THC2S)
Product Usage:
T-Cube One Step Multi-Drug Oral Fluid Test Cube is a rapid oral fluid Open, Classified |
DIS | None listed |
| May 18, 2018 | Guangzhou Wondfo Biotech Co., Ltd. TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO,COC20,METSO, OPl40,OXY20,THC2S)
Product Usage:
T-Cube One Step Multi-Drug Oral Fluid Test Cube is a rapid oral fluid screening test. The test is Open, Classified |
DIS | None listed |
| Dec 8, 2016 | OraSure Technologies, Inc. Barbiturates Intercept Micro-Plate EIA (enzyme immunoassay, barbiturate)
Product is intended for use by clinical laboratories in the qualitative determination of barbiturates in oral fluids. Terminated |
DIS | K001976 |
| Mar 1, 2012 | Alere San Diego Product Brand Names: Triage Drugs of Abuse Panel 8 Test Kit (K924476), Triage Drugs of Abuse
Panel Plus TCA (K973784), & Triage Drugs of Abuse Panel Plus PPX (K014247)
Model Number: 90008, 92002, & 92 Terminated |
DIS | K924476 K973784 |
| Jan 24, 2012 | Lin-Zhi International Inc Barbiturate Enzyme Immunoassay; R1
Antibody/Substrate Reagent (5000 tests and 500 tests);
Contains a mixture of monoclonal and polyclonal anti-barbiturate antibody, glucose 6-phosphate (G6P) and nicot Terminated |
DIS | K032764 |
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