Other products from "POINTE SCIENTIFIC, INC."
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 00811727018335 60-MP0706-5 60-MP0706-5 Pointe Methamphetamine Calibrator (500 ng/mL) Cutoff 1 x 5 mL The Pointe Methamp Pointe Methamphetamine Calibrator (500 ng/mL) Cutoff 1 x 5 mL The Pointe Methamphetamine Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the Pointe Methamphetamine Reagent Set (Ref# 60-MP0700-100/60-MP0700-1L) on a number of automated clinical chemistry analyzers. DLJ Calibrators, Drug Specific 2 Pointe Methamphetamine Calibrator (500 ng/mL) Cutoff
2 00811727017987 60-PP0256-5 60-PP0256-5 Pointe Propoxyphene (PPX) Control (375 ng/mL) Level 2 1 x 5 mL The Pointe Propox Pointe Propoxyphene (PPX) Control (375 ng/mL) Level 2 1 x 5 mL The Pointe Propoxyphene (PPX) Controls are for use as assayed quality control materials to monitor the precision of the Pointe Propoxyphene (PPX) Reagent Set (Ref# 60-PP0240-100/60-PP0240-1L) on a number of automated clinical chemistry analyzers. LAS Drug Specific Control Materials 1 Pointe Propoxyphene (PPX) Control (375 ng/mL) Level 2
3 00811727017970 60-PP0254-5 60-PP0254-5 Pointe Propoxyphene (PPX) Control (225 ng/mL) Level 1 1 x 5 mL The Pointe Propox Pointe Propoxyphene (PPX) Control (225 ng/mL) Level 1 1 x 5 mL The Pointe Propoxyphene (PPX) Controls are for use as assayed quality control materials to monitor the precision of the Pointe Propoxyphene (PPX) Reagent Set (Ref# 60-PP0240-100/60-PP0240-1L) on a number of automated clinical chemistry analyzers. LAS Drug Specific Control Materials 1 Pointe Propoxyphene (PPX) Control (225 ng/mL) Level 1
4 00811727015822 14-HB936-200 14-HB936-200 Pointe Direct Bilirubin Reagent packaged for the BS480 analyzer. 4x40mL, 4x10mL Pointe Direct Bilirubin Reagent packaged for the BS480 analyzer. 4x40mL, 4x10mL Kit. For the quantitative determination of direct bilirubin in serum on the BS480 analyzers. For in vitro diagnostic use only. CIG Diazo Colorimetry, Bilirubin 2 Pointe Direct Bilirubin for BS480
5 00811727017550 60-MA1704-15 60-MA1704-15 Pointe Multi-Analyte Set C Urine DAU Low Calibrator 1 x 15 mL The Pointe Multi-A Pointe Multi-Analyte Set C Urine DAU Low Calibrator 1 x 15 mL The Pointe Multi-Analyte Set C Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of drugs of abuse enzyme immunoassays for the detection of cocaine metabolite, d-methamphetamine, methadone, morphine, oxazepam, and secobarbital in human urine on a number of automated clinical chemistry analyzers. DKB Calibrators, Drug Mixture 2 Pointe Multi-Analyte Set C Urine DAU Low Calibrator
6 00811727015778 14-C7510-480 14-C7510-480 Pointe Cholesterol packaged to use on the BS480 Analyzer. 8x60mL Kit. For the qu Pointe Cholesterol packaged to use on the BS480 Analyzer. 8x60mL Kit. For the quantitative determination of Total Cholesterol in serum. For in vitro diagnostic use. CHH Enzymatic Esterase--Oxidase, Cholesterol 1 Pointe Cholesterol on BS480
7 00811727011060 C7568-CTL C7568-CTL These C-Reactive Protein Controls are intended for use in C-Reactive Protein (Hi These C-Reactive Protein Controls are intended for use in C-Reactive Protein (High Sensitivity) Wide Range test systems to validate performance of the assay. The controls may also be useful in assessing test precision or analytical errors.2 For in vitro diagnostic use only. DCK C-Reactive Protein, Antigen, Antiserum, And Control 2 POINTE SCIENTIFIC CRP Control Set
8 00811727010575 B7550-STD B7550-STD Intended for use as an BUN (Urea Nitrogen) standard for standardization or calib Intended for use as an BUN (Urea Nitrogen) standard for standardization or calibration of Urease/GLDH, BUN (Urea Nitrogen) procedures. CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen 2 POINTE SCIENTIFIC BUN Standard
9 00811727010391 A7561-625 A7561-625 For the quantitative determination of Aspartate Aminotransferase (AST) in human serum. POINTE SCIENTIFIC AST (SGOT) Liquid
10 00811727010384 A7561-450 A7561-450 For the quantitative determination of Aspartate Aminotransferase (AST) in human serum. CIT Nadh Oxidation/Nad Reduction, Ast/Sgot 2 POINTE SCIENTIFIC AST (SGOT) Liquid
11 00811727010377 A7561-150 A7561-150 For the quantitative determination of Aspartate Aminotransferase (AST) in human serum. CIT Nadh Oxidation/Nad Reduction, Ast/Sgot 2 POINTE SCIENTIFIC AST (SGOT) Liquid
12 00811727013040 HI904-498 HI904-498 Iron Reagent is for the quantitative determination of iron (ferrozine) in serum Iron Reagent is for the quantitative determination of iron (ferrozine) in serum on Hitachi analyzers. For in vitro diagnostic use only.6 x 66ml, 6 x 17ml JIY Photometric Method, Iron (Non-Heme) 1 Pointe Scientific Inc. Iron
13 00811727012999 HC922-300 HC922-300 CK Reagent is for the quantitative determination of creatine kinase activity in CK Reagent is for the quantitative determination of creatine kinase activity in serum on Hitachi analyzers. CGS Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes 2 Pointe Scientific, Inc. CK
14 00811727017406 60-EA0440-1L 60-EA0440-1L Pointe Ethyl Alcohol Reagent Set 1 x 1000 mL R1, 1 x 375 mL R2 The Pointe Ethyl Pointe Ethyl Alcohol Reagent Set 1 x 1000 mL R1, 1 x 375 mL R2 The Pointe Ethyl Alcohol Reagent Set is intended for the quantitative determination of ethyl alcohol in human urine, serum or plasma. The assay is designed for prescription use with a number of automated clinical chemistry analyzers. DIC Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method 2 Pointe Ethyl Alcohol Reagent Set
15 00811727017390 60-EA0440-100 60-EA0440-100 Pointe Ethyl Alcohol Reagent Set 1 x 100 mL R1, 1 x 37.5 mL R2 The Pointe Ethyl Pointe Ethyl Alcohol Reagent Set 1 x 100 mL R1, 1 x 37.5 mL R2 The Pointe Ethyl Alcohol Reagent Set is intended for the quantitative determination of ethyl alcohol in human urine, serum or plasma. The assay is designed for prescription use with a number of automated clinical chemistry analyzers. DIC Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method 2 Pointe Ethyl Alcohol Reagent Set
16 00811727011886 M7562-100 M7562-100 Pointe Scientific, Inc. Microalbumin Reagent for the quantitative determination Pointe Scientific, Inc. Microalbumin Reagent for the quantitative determination of low levels of albumin in urine by immunoturbidimetric assay. For in vitro diagnostic use.4 x 20 ml., 2 x 10 ml. JIT,DDZ Calibrator, Secondary,Albumin, Fitc, Antigen, Antiserum, Control 2 Pointe Scientific, Inc. Microalbumin
17 00811727016034 16-HA965-223 16-HA965-223 Pointe Amylase Reagent packaged for use on the Mindray BA800. 3 x 63ml R1, 2 x Pointe Amylase Reagent packaged for use on the Mindray BA800. 3 x 63ml R1, 2 x 17ml R2. For the quantitative kinetic determination of a-amylase activity in human serum. For in vitro diagnostic use only. CIJ Saccharogenic, Amylase 2 Pointe Amylase Reagent
18 00811727016072 16-C7548-240 16-C7548-240 Pointe Creatinine, Enzymatic Reagent packaged for use on the Mindray BA800. 3 x Pointe Creatinine, Enzymatic Reagent packaged for use on the Mindray BA800. 3 x 60ml R1, 3 x 20ml R2. For the quantitative determination of C-reactive protein in serum or plasma by latex particle enhanced immunoturbidimetric assay. For in vitro diagnostic use only. JFY Enzymatic Method, Creatinine 2 Pointe Creatinine, Enzymatic Reagent
19 00811727015907 14-L7572-200 14-L7572-200 Pointe Lactate Dehydrogenase Reagent packaged for use on the Mindray BS480. 4 x Pointe Lactate Dehydrogenase Reagent packaged for use on the Mindray BS480. 4 x 40ml R1, 4 x 10ml R2. For the in vitro quantitative kinetic determination of lactate dehydrogenase activity in serum. CFJ Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase 2 Pointe Lactate Dehydrogenase Reagent
20 00811727015884 14-HI904-350 14-HI904-350 Pointe Total Iron Reagent packaged for use on the BS480 Analyzer. 5x58mL Buffer, Pointe Total Iron Reagent packaged for use on the BS480 Analyzer. 5x58mL Buffer, 5x12mL Color Kit. For the quantitative determination of iron and total iron-binding capacity in serum. For in vitro diagnostic use only. JIY Photometric Method, Iron (Non-Heme) 1 Pointe Total Iron for the BS480
21 00811727015211 T8007-96 T8007-96 Pointe Scientific, Inc. HSV-1 & 2 IgG Reagent is for the qualitative, and semi-q Pointe Scientific, Inc. HSV-1 & 2 IgG Reagent is for the qualitative, and semi-quantitative detection of human IgG antibodies to type 1 and type 2 herpes simplex virus (HSV) in human serum by enzyme immunoassay. To aid in the evaluation of the patient's immunological history with HSV, including women of childbearing age. These reagents have not received FDA clearance for use in testing blood or plasma donors. 96 tests. LGC Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific 2 Pointe Scientific, Inc. HSV-1 & 2 IgG
22 00811727015051 OH945-480 OH945-480 Pointe Scientific, Inc. autoHDL Cholesterol Reagent is for the quantitative dete Pointe Scientific, Inc. autoHDL Cholesterol Reagent is for the quantitative determination high-density lipoprotein cholesterol in human serum or plasma. For in vitro diagnostic use only. Packaged for use on Olympus Analyzers. 6 x 60ml, 6 x 20ml LBR Ldl & Vldl Precipitation, Hdl 1 Pointe Scientific, Inc. autoHDL Cholesterol
23 00811727014979 OC702-180 OC702-180 Pointe Scientific, Inc. Carbon Dioxide Reagent is for the quantitative determina Pointe Scientific, Inc. Carbon Dioxide Reagent is for the quantitative determination of Carbon Dioxide in serum, packaged for use on Olympus analyzers. For in vitro diagnostic use only.4 x 45ml KHS Enzymatic, Carbon-Dioxide 2 Pointe Scientific, Inc. Carbon Dioxide
24 00811727014955 OB952-482 OB952-482 Pointe Scientific, Inc. BUN Reagent is for the quantitative determination of ure Pointe Scientific, Inc. BUN Reagent is for the quantitative determination of urea nitrogen in serum on Olympus Analyzers. For in vitro diagnostic use only.6 x 66ml, 2 x 43ml CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen 2 Pointe Scientific, Inc. BUN
25 00811727014924 OA961-487 OA961-487 Pointe Scientific, Inc. AST Reagent is for the quantitative determination of Asp Pointe Scientific, Inc. AST Reagent is for the quantitative determination of Aspartate Aminotransferase (AST) in human serum. Packaged with barcodes for use on AU400, AU480 and AU640.6 x 67ml, 5 x 17ml CIT Nadh Oxidation/Nad Reduction, Ast/Sgot 2 Pointe Scientific, Inc. AST
26 00811727014900 OA902-702 OA902-702 Pointe Scientific, Inc. Alkaline Phosphatase Reagent is for the quantitative det Pointe Scientific, Inc. Alkaline Phosphatase Reagent is for the quantitative determination of alkaline phosphatase in human serum. For in vitro diagnostic use only. Packaged with barcodes for use on AU400, AU480 and AU640.5 x 50ml, 4 x 13ml. Pointe Scientific, Inc. Alkaline Phosphatase
27 00811727014771 HL956-1400 HL956-1400 Pointe Lactate Dehydrogenase Reagent is for the quantitative kinetic determinati Pointe Lactate Dehydrogenase Reagent is for the quantitative kinetic determination of lactate dehydrogenase activity in serum on Hitachi analyzers. For in vitro diagnostic use only.1 x 1L, 1 x 400ml CFJ Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase 2 Pointe Scientific, Inc. LD
28 00811727011091 F7546-CTL F7546-CTL These Fructosamine Controls are intended for use in fructosamine test systems to These Fructosamine Controls are intended for use in fructosamine test systems to validate performance of the assay. The controls may also be useful in assessing test precision or analytical errors.1 For in vitro diagnostic use only. LCP Assay, Glycosylated Hemoglobin 2 POINTE SCIENTIFIC Fructosamine Control Set
29 00811727017031 60-ME0220-1L 60-ME0220-1L Pointe Methadone Reagent Set 1 x 1000 mL R1, 1 x 375 mL R2 The Pointe Methadone Pointe Methadone Reagent Set 1 x 1000 mL R1, 1 x 375 mL R2 The Pointe Methadone Reagent Set is intended for the qualitative and semi-quantitative determination of methadone in human urine at a cutoff value of 300 ng/mL. The assay is designed for prescription use with a number of automated clinical chemistry analyzers. DJR Enzyme Immunoassay, Methadone 2 Pointe Methadone Reagent Set
30 00811727014245 13-G7540-STD 13-G7540-STD This product is for the purpose of standardizing results obtained from run to ru This product is for the purpose of standardizing results obtained from run to run in the quantitative determination of human glycohemoglobin (HbA1) in blood by cation exchange resin.1 x 1 ml LCP Assay, Glycosylated Hemoglobin 2 Pointe Scientific, Inc. Glyco Standard
31 00811727014214 13-G7521-1000 13-G7521-1000 Reagent for the quantitative determination of Glucose in serum. For in vitro di Reagent for the quantitative determination of Glucose in serum. For in vitro diagnostic use only.1 x 1000 ml CGA Glucose Oxidase, Glucose 2 Pointe Scientific, Inc. Glucose Ox
32 00811727014207 13-G7521-500 13-G7521-500 Reagent for the quantitative determination of Glucose in serum. For in vitro di Reagent for the quantitative determination of Glucose in serum. For in vitro diagnostic use only.1 x 500 ml CGA Glucose Oxidase, Glucose 2 Pointe Scientific, Inc. Glucose Ox
33 00811727014191 13-G7521-120 13-G7521-120 Reagent for the quantitative determination of Glucose in serum. For in vitro di Reagent for the quantitative determination of Glucose in serum. For in vitro diagnostic use only.1 x 120 ml CGA Glucose Oxidase, Glucose 2 Pointe Scientific, Inc. Glucose Ox
34 00811727014184 13-G7518-STD 13-G7518-STD Reagent intended for use as an glucose standard for standardization or calibrati Reagent intended for use as an glucose standard for standardization or calibration of glucose hexokinase or oxidase procedures.1 x 100 mg/dl CGA Glucose Oxidase, Glucose 2 Pointe Scientific, Inc. Glucose Standard
35 00811727013743 13-A7516-R2-30 13-A7516-R2-30 For the quantitative determination of Alanine Aminotransferase in serum. CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes 2 Alk Phos R2 (w/ssa#)
36 00811727013736 13-A7516-R2-125 13-A7516-R2-125 For the quantitative determination of alkaline phosphatase in human serum. For For the quantitative determination of alkaline phosphatase in human serum. For in vitro diagnostic use only. CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes 2 Alk Phos R2 (w/ssa#)
37 00811727013705 13-A7502-STD 13-A7502-STD Intended for use as an albumin standard for standardization or calibration of br Intended for use as an albumin standard for standardization or calibration of bromocresol green (BCG) dye-binding albumin procedures. CIX Bromcresol Green Dye-Binding, Albumin 2 Albumin Std (w/ssa#)
38 00811727013699 13-A7502-500 13-A7502-500 For the quantitative determination of Albumin in serum. CIX Bromcresol Green Dye-Binding, Albumin 2 Albumin (w/ssa#)
39 00811727013682 13-A7502-120 13-A7502-120 For the quantitative determination of Albumin in serum. CIX Bromcresol Green Dye-Binding, Albumin 2 Albumin (w/ssa#)
40 00811727013668 12-T7532-160 12-T7532-160 For the in vitro quantitative determination of Triglycerides in serum or plasma. CDT Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides 1 Triglyceride
41 00811727013644 12-P7516-160 12-P7516-160 For the quantitative determination of Inorganic Phosphorus in serum. 4 x 40 ml CEO Phosphomolybdate (Colorimetric), Inorganic Phosphorus 1 Phosphorus
42 00811727016768 60-HY0776-5 60-HY0776-5 Pointe Hydrocodone 100 Level 2 Control (125 ng/mL) 1 x 5 mL The Pointe Hydrocodo Pointe Hydrocodone 100 Level 2 Control (125 ng/mL) 1 x 5 mL The Pointe Hydrocodone 100 Controls are for use as assayed quality control materials to monitor the precision of the Pointe Hydrocodone 100 Reagent Set (Ref# 60-HY0760-100/60-HY0760-1L) on a number of automated clinical chemistry analyzers. LAS Drug Specific Control Materials 1 Pointe Hydrocodone 100 Level 2 Control (125 ng/mL)
43 00811727013583 12-HB979-192 12-HB979-192 For the quantitative determination of total bilirubin in serum on Hitachi analyz For the quantitative determination of total bilirubin in serum on Hitachi analyzers. For in vitro diagnostic use only. CIG Diazo Colorimetry, Bilirubin 2 Total Bilirubin
44 00811727013576 12-HB936-156 12-HB936-156 For the quantitative determination of direct bilirubin in serum on Hitachi analy For the quantitative determination of direct bilirubin in serum on Hitachi analyzers. For in vitro diagnostic use only. CIG Diazo Colorimetry, Bilirubin 2 Direct Bilirubin
45 00811727013439 12-B7552-150 12-B7552-150 For the quantitative determination of urea nitrogen in serum. For in vitro diag For the quantitative determination of urea nitrogen in serum. For in vitro diagnostic use only. CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen 2 POINTE SCIENTIFIC BUN
46 00811727016973 60-OP0666-5 60-OP0666-5 Pointe Opiates 2000 Calibrator (Morphine 2000 ng/mL) 1 x 5 mL The Pointe Opiates Pointe Opiates 2000 Calibrator (Morphine 2000 ng/mL) 1 x 5 mL The Pointe Opiates 2000 Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the Pointe Opiates 2000 Reagent Set (Ref# 60-OP0660-100/60-OP0660-1L) on a number of automated clinical chemistry analyzers. DLJ Calibrators, Drug Specific 2 Pointe Opiates 2000 Calibrator (Morphine 2000 ng/mL)
47 00811727013064 HL956-295 HL956-295 LD Reagent is for the quantitative kinetic determination of lactate dehydrogenas LD Reagent is for the quantitative kinetic determination of lactate dehydrogenase activity in serum on Hitachi analyzers. For in vitro diagnostic use only.5 x 42ml, 5 x 17ml. CFJ Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase 2 Pointe Scientific, Inc. LD
48 00811727018373 60-MP0716-5 60-MP0716-5 Pointe Methamphetamine Control (625 ng/mL) Level 2 1 x 5 mL The Pointe Methamphe Pointe Methamphetamine Control (625 ng/mL) Level 2 1 x 5 mL The Pointe Methamphetamine Controls are for use as assayed quality control materials to monitor the precision of the Pointe Methamphetamine Reagent Set (Ref# 60-MP0700-100/60-MP0700-1L) on number of automated clinical chemistry analyzers. LAS Drug Specific Control Materials 1 Pointe Methamphetamine Control (625 ng/mL) Level 2
49 00811727018120 60-MM0410-5 60-MM0410-5 Pointe Methadone Metabolite (EDDP) Calibrator (500 ng/mL) High 1 x 5 mL The Poin Pointe Methadone Metabolite (EDDP) Calibrator (500 ng/mL) High 1 x 5 mL The Pointe Methadone Metabolite (EDDP) 100 Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the Pointe Methadone Metabolite (EDDP) Reagent Set (Ref# 60-MM0380-100/60-MM0380-1L) at the cutoff value of 100 ng/mL on automated clinical chemistry analyzers. DLJ Calibrators, Drug Specific 2 Pointe Methadone Metabolite (EDDP) Calibrator (500 ng/mL) High
50 00811727018113 60-MM0408-5 60-MM0408-5 Pointe Methadone Metabolite (EDDP) Calibrator (250 ng/mL) Intermediate 1 x 5 mL Pointe Methadone Metabolite (EDDP) Calibrator (250 ng/mL) Intermediate 1 x 5 mL The Pointe Methadone Metabolite (EDDP) 100 Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the Pointe Methadone Metabolite (EDDP) Reagent Set (Ref# 60-MM0380-100/60-MM0380-1L) at the cutoff value of 100 ng/mL on automated clinical chemistry analyzers. DLJ Calibrators, Drug Specific 2 Pointe Methadone Metabolite (EDDP) Calibrator (250 ng/mL) Intermediate
Other products with the same Product Code "DJR"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 00884883012912 10018522 DRI Methadone Metabolite Assay MICROGENICS CORPORATION
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4 00884883012493 10016403 DRI Methadone Assay MICROGENICS CORPORATION
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8 00884883004214 100087 CEDIA Methadone Metabolite (EDDP) Assay MICROGENICS CORPORATION
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10 00884883003392 0596 DRI Methadone Assay MICROGENICS CORPORATION
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15 00868754000208 X13-DT13A X13-DT13A THC50/COC150; OPI300/MET500; AMP500/BZO300; BAR300/MTD300; BUPG10/TCA1000; MDMA5 THC50/COC150; OPI300/MET500; AMP500/BZO300; BAR300/MTD300; BUPG10/TCA1000; MDMA500/OXY100 w/ Cr,Ni,pH,Bl,S.G. drugs of abuse test cup Coastline Explorer Cup COASTLINE MEDICAL MANAGEMENT, LLC
16 00868401000254 RC12TCA RC12TCA (BZO/BAR)+(COC/THC)+(MET/OPI)+(OXY/MDMA)+(PCP/AMP)+BUP+MTD with Cr, Ni, pH, Bl, S.G. RealityCHECK Drugs of Abuse Cup WOLFE & ASSOCIATES INC
17 00867802000290 BS-0610S 301 The xReader System consists of a small, portable high resolution flatbed scanner The xReader System consists of a small, portable high resolution flatbed scanner, customized Software, and lateral flow tests that are intended for use in the system. The scanner has a custom Scanner Lid with an opening for the test device, and a Scanner Stand, which places the scanner bed at the appropriate angle for running and reading the test devices. The xReader System is intended for use with the xCup, which is a rapid, single use, disposable immunochromatographic test for the qualitative detection of drugs of abuse in human urine.The xReader System detects drug classes at the following cutoff concentrations: Amphetamines at 500 ng/mL; Barbiturates at 300 ng/mL; Benzodiazepines at 300 ng/mL; Cocaine at 150 ng/mL; Methamphetamines at 500 ng/mL; Methadone at 300 ng/mL; Morphine at 300 ng/mL and 2000 ng/mL; Oxycodone at 100 ng/mL; Phencyclidine at 25 ng/mL; and Marijuana at 50 ng/mL. Configurations of the xCup may consist of any combination of the listed drug analytes.The xCup test devices are run in the xReader System according to their specific instructions for use. At the conclusion of the test an image is captured and the Software determines whether the colored test lines for each analyte are above or below the threshold associated with a Send to Lab or a Discard result. The Software also confirms the validity of the results by verifying the presence of control lines and analyzing the specimen validity. The xReader System is for in vitro diagnostic use and is intended for use in laboratories, point-of-care sites and workplaces by minimally trained users. The test is not intended for over-the-counter use. The xCup test devices cannot be read visually. xReader System ESCREEN, INC.
18 00863480002106 60B02 LifeSign QuikScreen 11: Amphetamine (AMP) 1000 ng/mlPhencyclidine (PCP) 25 ng/ml LifeSign QuikScreen 11: Amphetamine (AMP) 1000 ng/mlPhencyclidine (PCP) 25 ng/mlMethamphetamine (MET) 1000 ng/mlOpiate (OPI) 2000 ng/mlBarbiturates (BAR) 300 ng/mlBenzodiazepine (BZD) 300 ng/mlMarijuana (THC) 50 ng/mlMethadone (MAD) 300 ng/mlOxycodone (OXY) 100 ng/mlTricyclic Antidepressants (TCA) 1000 ng/mlCocaine (COC) 300ng/ml LifeSign QuikScreen 11 LIFESIGN L.L.C.
19 00859144006238 61127D 61127D AMP/OPI300/COC/THC/MET/BZO/BAR/MTD/OXY/MDMA/BUP drugs of abuse test cup DrugSmart Cup TWIN SPIRIT INC.
20 00859144006221 61230D 61230D THC/COC/OPI2000/AMP/MET/PCP/MDMA/BAR/BZO/MTD/PPX/OXY drugs of abuse test cup DrugSmart Cup TWIN SPIRIT INC.
21 00859144006153 60960D 60960D THC/COC/OPI/AMP/MET/BZO/MTD/OXY/BUP drugs of abuse test cup DrugSmart Cup TWIN SPIRIT INC.
22 00859144006139 61020D 61020D THC/COC/AMP/PCP/OPI/MET/BAR/BZO/MTD/OXY drugs of abuse test cup DrugSmart Cup TWIN SPIRIT INC.
23 00859144006122 61023D 61023D THC/COC/BAR/BZO/MET/OPI300/MTD/PPX/OXY/MDMA drugs of abuse test cup DrugSmart Cup TWIN SPIRIT INC.
24 00859144006092 61055D 61055D THC/COC/AMP/MET/BAR/BZO/OPI/PCP/MDMA/MTD drugs of abuse test cup DrugSmart Cup TWIN SPIRIT INC.
25 00859144006085 61085D 61085D THC/COC/AMP/MET/BAR/BZO/OPI/PCP/PPX/MTD drugs of abuse test cup DrugSmart Cup TWIN SPIRIT INC.
26 00859144006078 61205D 61205D COC/THC/MET/OPI/AMP/MDMA/BAR/BZO/MTD/PPX/OXY/BUP drugs of abuse test cup DrugSmart Cup TWIN SPIRIT INC.
27 00859144006061 61210D 61210D COC/THC/MET/OPI/AMP/BAR/BZO/MTD/PCP/PPX/OXY/BUP drugs of abuse test cup DrugSmart Cup TWIN SPIRIT INC.
28 00859144006054 C-61203D C-61203D THC, COC, OPI300, AMP, MET, PCP, MDMA, BAR, BZO, MTD, TCA, OXY drugs of abuse te THC, COC, OPI300, AMP, MET, PCP, MDMA, BAR, BZO, MTD, TCA, OXY drugs of abuse test cup (CLIA WAIVED) DrugSmart Cup TWIN SPIRIT INC.
29 00859144006047 C-61103D C-61103D THC, COC, OPI300, AMP, MET, PCP, MDMA, BAR, BZO, MTD, OXY drugs of abuse test cu THC, COC, OPI300, AMP, MET, PCP, MDMA, BAR, BZO, MTD, OXY drugs of abuse test cup (CLIA WAIVED) DrugSmart Cup TWIN SPIRIT INC.
30 00859144006030 C-61026D C-61026D THC, COC, OPI300, AMP, MET, PCP, BAR, BZO, MTD, OXY drugs of abuse test cup (CLIA WAIVED) DrugSmart Cup TWIN SPIRIT INC.
31 00859144006023 C-60823D C-60823D THC, COC, OPI300, AMP, MET, BZO, MTD, OXY drugs of abuse test cup (CLIA WAIVED) DrugSmart Cup TWIN SPIRIT INC.
32 00859144006016 C-60820D C-60820D THC, COC, OPI, AMP, MET, BZO, MTD, OXY drugs of abuse test cup (CLIA WAIVED) DrugSmart Cup TWIN SPIRIT INC.
33 00858998006999 PSCupA-12BB-W PSCupA-12BB-W Drugs of Abuse Cup, (COC/THC)+(MET1000/OPI2000)+(MTD/TCA)+(OXY/MDMA)+(PCP/AMP)+B Drugs of Abuse Cup, (COC/THC)+(MET1000/OPI2000)+(MTD/TCA)+(OXY/MDMA)+(PCP/AMP)+BAR+BZO with Cr, Ni, pH, Bl, S.G. ProScreen INSTANT TECH SUBSIDIARY ACQUISITION
34 00858998006975 PSCup-10CT PSCup-10CT Drugs of Abuse Cup, (COC/THC)+(MET1000/OPI2000)+(PCP/AMP)+BAR+BZO+MDMA+MTD ProScreen INSTANT TECH SUBSIDIARY ACQUISITION
35 00858998006951 PSD-10M PSD-10M Drugs of Abuse Test Card, (BZO/BAR)+(MET1000/OPI2000)+(PCP/AMP)+COC+MDMA+MTD+THC ProScreen INSTANT TECH SUBSIDIARY ACQUISITION
36 00858998006937 PSD-10APO300 PSD-10APO300 Drugs of Abuse Test Card, (BZO/BAR)+(COC/THC)+(OXY/MDMA)+AMP+MTD+OPI300+PPX ProScreen INSTANT TECH SUBSIDIARY ACQUISITION
37 00858998006920 PSD-9P PSD-9P Drugs of Abuse Test Card, (BZO/BAR)+(COC/THC)+(MET1000/OPI2000)+(PCP/AMP)+MTD ProScreen INSTANT TECH SUBSIDIARY ACQUISITION
38 00858998006906 PSD-8BUP PSD-8BUP Drugs of Abuse Test Card, (COC/THC)+AMP+BZO+BUP+MET+OPI300+OXY ProScreen INSTANT TECH SUBSIDIARY ACQUISITION
39 00858998006890 PSD-7MPB PSD-7MPB Drugs of Abuse Test Card, (COC/THC)+(MET1000/OPI2000)+BZO+MTD+PCP ProScreen INSTANT TECH SUBSIDIARY ACQUISITION
40 00858998006852 PSD-6MTDBO300 PSD-6MTDBO300 Drugs of Abuse Test Card, (COC/THC)+THC+BZO+MTD+OPI300+OXY ProScreen INSTANT TECH SUBSIDIARY ACQUISITION
41 00858998006746 PSP-10PPX PSP-10PPX Drugs of Abuse Test Cassette, (BAR/BZO)+(COC/THC)+(MET1000/OPI2000)+(PCP/AMP)+MTD+PPX ProScreen INSTANT TECH SUBSIDIARY ACQUISITION
42 00858998006739 PSP-10M PSP-10M Drugs of Abuse Test Cassette, (BAR/BZO)+(COC/THC)+(MET1000/OPI2000)+(PCP/AMP)+MTD+MDMA ProScreen INSTANT TECH SUBSIDIARY ACQUISITION
43 00858998006715 PSCupA-12PP PSCupA-12PP Drugs of Abuse Cup, (BZO/BAR)+(COC/THC)+(MET1000/OPI2000)+(OXY/MDMA)+(PCP/AMP)+M Drugs of Abuse Cup, (BZO/BAR)+(COC/THC)+(MET1000/OPI2000)+(OXY/MDMA)+(PCP/AMP)+MTD+PPX with Cr, Ni, pH, Bl, S.G. ProScreen INSTANT TECH SUBSIDIARY ACQUISITION
44 00858998006708 PSCupA-12TBU PSCupA-12TBU Drugs of Abuse Cup, (BZO/BAR)+(COC/THC)+(MET1000/OPI2000)+(MTD/TCA)+(OXY/MDMA)+A Drugs of Abuse Cup, (BZO/BAR)+(COC/THC)+(MET1000/OPI2000)+(MTD/TCA)+(OXY/MDMA)+AMP+BUP with Cr, Ni, pH, Bl, S.G. ProScreen INSTANT TECH SUBSIDIARY ACQUISITION
45 00858998006685 PSCupA-12M-W PSCupA-12M-W Drugs of Abuse Cup, CLIA Waived, (BZO/BAR)+(COC/THC)+(MET1000/OPI2000)+(MTD/TCA) Drugs of Abuse Cup, CLIA Waived, (BZO/BAR)+(COC/THC)+(MET1000/OPI2000)+(MTD/TCA)+(OXY/MDMA)+(PCP/AMP) with Cr, Ni, pH, Bl, S.G. ProScreen INSTANT TECH SUBSIDIARY ACQUISITION
46 00858998006678 PSCupA-12M PSCupA-12M Drugs of Abuse Cup, (BZO/BAR)+(COC/THC)+(MET1000/OPI2000)+(MTD/TCA)+(OXY/MDMA)+( Drugs of Abuse Cup, (BZO/BAR)+(COC/THC)+(MET1000/OPI2000)+(MTD/TCA)+(OXY/MDMA)+(PCP/AMP) with Cr, Ni, pH, Bl, S.G. ProScreen INSTANT TECH SUBSIDIARY ACQUISITION
47 00858998006654 PSCupA-10MBO PSCupA-10MBO Drugs of Abuse Cup, (BZO/BAR)+(COC/THC)+(MET1000/OPI2000)+AMP+MTD+OXY+PPX with C Drugs of Abuse Cup, (BZO/BAR)+(COC/THC)+(MET1000/OPI2000)+AMP+MTD+OXY+PPX with Cr, Ni, pH, Bl, S.G. ProScreen INSTANT TECH SUBSIDIARY ACQUISITION
48 00858998006647 PSCupA-10AM PSCupA-10AM Drugs of Abuse Cup, (BZO/BAR)+(COC/THC)+(MET1000/OPI2000)+(OXY/MDMA)+AMP+MTD wit Drugs of Abuse Cup, (BZO/BAR)+(COC/THC)+(MET1000/OPI2000)+(OXY/MDMA)+AMP+MTD with Cr, Ni, pH, Bl, S.G. ProScreen INSTANT TECH SUBSIDIARY ACQUISITION
49 00858998006623 PSD-9CT PSD-9CT Drugs of Abuse Test Card, (COC/THC)+(MET1000/OPI2000)+(PCP/AMP)+BAR+BZO+MTD ProScreen INSTANT TECH SUBSIDIARY ACQUISITION
50 00858998006562 PSCup-10MMO300 PSCup-10MMO300 Drugs of Abuse Cup, (BAR/BZO)+(COC/THC)+(OXY/MDMA)+AMP+MET1000+MTD+OPI300 ProScreen INSTANT TECH SUBSIDIARY ACQUISITION