Panels › Clinical Toxicology › Product code DIO · Class 2
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Regulation 862.3250
0510(k)s in 12 months (145 all time)
0recalls in 12 months (23 all time)
12recalls that name a 510(k)
Top companies in DIO
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 18, 2020 | Ameditech Inc Drug Screening Component: Uncut Sheets
Part Number/ Description/ LOT Number
100163/ EDI OPI (300) Uncut Sheet-Card /187876,
100195/ EDI PPX Uncut Sheet-Card/ 187877,
160130/ EDI COC Uncut Sheet-Cup/ 1 Terminated |
DIO | K113046 K113501 |
| Aug 18, 2020 | Ameditech Inc ToxCup Drug Screen Cup (AMT Item Number/ AMT Description):
HT29A/"ToxCup Drug Screen Cup
COC300/MET500/OPI300/THC50/AMP1000/PCP25/OXY100
Adulteration Screen for CR - NI - PH - BL - S.G.",
DT14/ "T Terminated |
DIO | K032057 K122633 |
| Aug 18, 2020 | Ameditech Inc TDDA Drugs of Abuse Cup(AMT Item/ AMT Description):
TDDA-6MBAU-CUP /"TDDA Drugs of Abuse Cup
AMP300/BZO200/COC300/MET300/OPI300/ THC50 with Cr, Ni, pH, Bl, S.G." Terminated |
DIO | None listed |
| Aug 18, 2020 | Ameditech Inc QuickTox Drug Screen DipCard(AMT Item/ AMT Description):
QT70/ "QuickTox Drug Screen Dipcard 11 Drug Detection: COC300+OPI300+MET500+THC50+AMP1000+PCP25+BZO300+BAR300+MTD300+OXY100+MDMA500",
QT88/ " Terminated |
DIO | None listed |
| Aug 18, 2020 | Ameditech Inc Fastect II Drug Screen Dipstick Test Single Drug Detection (AMT Item Number/ AMT Description):
MF25/ "Fastect II Drug Screen Dipstick Test Single Drug Detection: BUP10", QF09/"Fastect II Drug Screen Terminated |
DIO | K022355 K030113 |
| Aug 18, 2020 | Ameditech Inc Alere iCup Drug Detection (AMT Item Number/ AMT Description):
I-DXA-10/ "Alere" iCup Dx 10 Drug Detection + Adulteration AMP/BAR/BZO/COC/MET/MDMA/MTD/MOP/OXY/THC
Bl, Cr, Ni, pH, SG",
I-DXA-13B/"Aler Terminated |
DIO | K052115 K122633 |
| Aug 18, 2020 | Ameditech Inc Alere iScreen Multi Drug Detection (AMT Item Number/ AMT Description):
X11-IS12-DX / "Alere iScreen" Dx Multi-Drugs of Abuse Dip Test
12 Drug Detection:AMP1000+BAR300+BZO300+COC300+THC50+MTD300+MET5 Terminated |
DIO | K082508 |
| Aug 18, 2020 | Ameditech Inc Alere iScreen Single Drug Detection (AMT Item Number/ AMT Description):
X11-IS1 BUP-DX/ "Alere iScreen" Dx Single Dip Card Single Drug Detection: Buprenorphine (BUP)",
X11-IS1 BAR-DX /"Alere iScreen" Terminated |
DIO | K022335 K082508 |
| Dec 20, 2017 | OraSure Technologies, Inc. Cocaine Metabolite MICRO-PLATE EIA, Catalog Number: 1122SC, UDI: (0100608337000429(17)180228(10)000 Terminated |
DIO | K982061 |
| Jul 5, 2016 | Branan Medical Corporation AmediCheck Instant Test Cup, Part No. C-C0501A-3A
Product Usage:
The AmediCheck Instant Test Cup is an in vitro diagnostic test for the rapid detection of the following drugs in human urine. Drug Ana Terminated |
DIO | K082898 |
| Apr 24, 2014 | Branan Medical Corporation ToxCup Drug Screen Cup, Catalogue Numbers: HT15, HT15A, PT11, PT11A, PT15A, PT23A, a screening device for the detection of drugs and drug metabolites in human urine. For in vitro diagnostic use only. Terminated |
DIO | K032057 |
| Jan 23, 2014 | Ortho-Clinical Diagnostics VITROS Chemistry Products COCM Reagent Terminated |
DIO | K062123 |
| Sep 23, 2013 | Microgenics Corp DRI Cocaine Metabolite Assay, labeled as Multigent Cocaine Assay for Abbott Laboratories.
100 ml, IVD
Mfg by:
Microgenics Corporation,
46360 Fremont Blvd.
Fremont, CA 94538
The DRI Cocaine Metabolit Terminated |
DIO | K960187 |
| Aug 23, 2013 | Sarken, Inc. SARKEN STAT! 1- Panel Test Kit-COC
Product Usage- Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing). Terminated |
DIO | None listed |
| Aug 23, 2013 | Sarken, Inc. SARKEN STAT! Multi-Drug Test Panel
Product Usage- Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing). Terminated |
DIO | None listed |
| May 16, 2013 | Medtox Diagnostics Inc PROFILE-V MEDTOXScan Drugs of Abuse Test System.
For the rapid, qualitative detection of drugs of abuse in human urine, Terminated |
DIO | K080635 |
| Dec 15, 2005 | Bio-Rad Laboratories Inc Bio-Rad brand ''TOX/See Drug Screen Test'';
Catalog numbers: 1945182EX, 1945216, 194-5223 Terminated |
DIO | None listed |
| Dec 18, 2003 | Drug Free Enterprises Inc DrugCheck 5, in-vitro diagnostic test for drugs of abuse: AMP, COC, THC, OPI, MET. Terminated |
DIO | None listed |
| Sep 23, 2003 | Drug Free Enterprises Inc DrugCheck 9 Test Cup AMP/COC/OPI/THC/MET/BZD/BAR/PCP/MTD
Product Code 60925 Terminated |
DIO | None listed |
| Sep 23, 2003 | Drug Free Enterprises Inc DrugCheck 9 Test Cup AMP/COC/OPI/THC/MET/BZD/BAR/PCP/TCA
Product Code 60900 Terminated |
DIO | None listed |
| Sep 23, 2003 | Drug Free Enterprises Inc DrugCheck 8 Test Cup AMP/COC/OPI/THC/MET/BZD/BAR/PCP
Product Code 60800 Terminated |
DIO | None listed |
| Sep 23, 2003 | Drug Free Enterprises Inc Drug Check 4 Test Cup AMP/COC/OPI/THC
Product Code 60400, and 60410 Terminated |
DIO | None listed |
| Sep 23, 2003 | Drug Free Enterprises Inc DrugCheck 3 Test Cup COC/MET/THC
Product Code 60300 Terminated |
DIO | None listed |
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