No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00628063400393 | 265-30 | 265-30 | JFY | ENZYMATIC METHOD, CREATININE | 2 | ENZYMATIC CREATININE Assay | |
2 | 00628063400362 | 234-99 | 234-99 | CHH | ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL | 1 | CHOLESTEROL-SL | |
3 | 00628063400355 | 234-60 | 234-60 | CHH | ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL | CHOLESTEROL-SL | ||
4 | 00742860100215 | 1005 | 1005 | OSOM Ultra Flu A&B Controls 5 Test | GNX | ANTIGENS, CF (INCLUDING CF CONTROL), INFLUENZA VIRUS A, B, C | OSOM Ultra Flu A&B Controls 5 Test | |
5 | 00628063400676 | 80-4598-00 | 80-4598-00 | LBR | LDL & VLDL PRECIPITATION, HDL | 1 | N-geneous LDL Cholesterol Reagent (R1) | |
6 | 00628063400669 | 7120 | 7120 | LBR | LDL & VLDL PRECIPITATION, HDL | 1 | LDL Direct LS Cholesterol Reagent Kit | |
7 | 00742860001017 | 101 | 101 | JHI | Visual, pregnancy hCG, prescription use | OSOM hCG Urine 50 Test Kit | ||
8 | 00628063400539 | SK235-10 | SK235-10 | CFR | HEXOKINASE, GLUCOSE | GLUCOSE | ||
9 | 00628063401154 | SK350-CAL | SK350-CAL | JIT | Calibrator, secondary | 2 | HbA1c Calibrators | |
10 | 00628063401116 | SK252-20 | SK252-20 | DCF | ALBUMIN, ANTIGEN, ANTISERUM, CONTROL | 2 | Microalbumin | |
11 | 00628063400690 | 80-4604-00 | 80-4604-00 | LBR | LDL & VLDL PRECIPITATION, HDL | 1 | N-geneous LDL Cholesterol Reagent (R1) | |
12 | 00628063400652 | 327-30 | 327-30 | CFJ | NAD REDUCTION/NADH OXIDATION, LACTATE DEHYDROGENASE | 2 | LACTATE DEHRYDROGENASE-SL Assay | |
13 | 00628063400225 | SK284-20 | SK284-20 | CIG | DIAZO COLORIMETRY, BILIRUBIN | 2 | Total Bilirubin | |
14 | 00628063400164 | 247-30 | 247-30 | CIG | DIAZO COLORIMETRY, BILIRUBIN | 2 | DIRECT BILIRUBIN-SL Assay | |
15 | 00628063400089 | 328-30 | 328-30 | CJE | NITROPHENYLPHOSPHATE, ALKALINE PHOSPHATASE OR ISOENZYMES | 2 | ALKALINE PHOSPHATASE-SL | |
16 | 00742860100161 | 175 | 175 | LYR | Helicobacter pylori | OSOM H Pylori 25 Test Kit | ||
17 | 00628063401086 | SK273-40 | SK273-40 | DIC | ALCOHOL DEHYDROGENASE, SPECIFIC REAGENT FOR ETHANOL ENZYME METHOD | 2 | Ethanol Assay | |
18 | 00742860001475 | 147 | 147 | GTY | ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP. | OSOM Ultra Strep A 25 Test Kit | ||
19 | 00628063400867 | 511-40 | 511-40 | DKJ | COLORIMETRY, SALICYLATE | 2 | SALICYLATE-SL Assay | |
20 | 00628063400850 | SK117-20 | SK117-20 | CEO | Phosphomolybdate (colorimetric), inorganic phosphorus | 1 | PHOSPHORUS | |
21 | 00628063400799 | 175-12 | 175-12 | JGJ | PHOTOMETRIC METHOD, MAGNESIUM | MAGNESIUM Reagent | ||
22 | 00742860001024 | 102W | 102W | JHI | Visual, pregnancy hCG, prescription use | OSOM hCG Card 25 Test Kit | ||
23 | 00742860100093 | 138 | 138 | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | HCG SERUM CONTROL KIT | |
24 | 00628063401178 | SK350-BLK | SK350-BLK | JIT | Calibrator, secondary | HbA1c Blank Solution | ||
25 | 00628063401161 | SK350-QC | SK350-QC | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | HbA1c Controls | |
26 | 00628063401147 | SK350-60 | SK350-60 | PDJ,LCP | Hemoglobin A1c test system,ASSAY, GLYCOSYLATED HEMOGLOBIN | 2 | HbA1c Assay | |
27 | 00628063400454 | SM-052 | SM-052 | JJY | Multi-analyte controls, all kinds (assayed) | DC-TROL Level 1 | ||
28 | 00628063400430 | 250-20 | 250-20 | DCK | C-REACTIVE PROTEIN, ANTIGEN, ANTISERUM, AND CONTROL | 2 | Wide Range CRP Assay | |
29 | 00628063400140 | 319-30 | 319-30 | CIT | Nadh oxidation/nad reduction, ast/sgot | 2 | AST-SL | |
30 | 00628063400072 | SK200-10 | SK200-10 | CIX | BROMCRESOL GREEN DYE-BINDING, ALBUMIN | ALBUMIN | ||
31 | 00742860100222 | 1006 | 1006 | OSOM Ultra Flu A&B 25T Kit | PSZ | Devices detecting influenza A, B, and C virus antigens | OSOM Ultra Flu A&B 25T Kit | |
32 | 00742860100147 | 191 | 191 | GNX | ANTIGENS, CF (INCLUDING CF CONTROL), INFLUENZA VIRUS A, B, C | OSOM Influenza Control Kit | ||
33 | 00742860001499 | 149 | 149 | GTY | ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP. | OSOM Ultra Strep A 50 Test Kit | ||
34 | 00742860100178 | 176 | 176 | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | OSOM H. Pylori Control Kit | |
35 | 00742860001451 | 145 | 145 | KTN | SYSTEM, TEST, INFECTIOUS MONONUCLEOSIS | OSOM Mono 25 Test Kit | ||
36 | 00628063400935 | 153-90 | 153-90 | JMO | Ferrozine (colorimetric) iron binding capacity | 1 | UIBC-SL | |
37 | 00628063400928 | 153-10 | 153-10 | JMO | Ferrozine (colorimetric) iron binding capacity | 1 | UIBC-SL | |
38 | 00742860100048 | 755725 | 755725 | KTN | SYSTEM, TEST, INFECTIOUS MONONUCLEOSIS | MONO, MERIDIAN IMMUNO 25 Test Kit | ||
39 | 00628063400980 | SK283-10 | SK283-10 | CDQ | UREASE AND GLUTAMIC DEHYDROGENASE, UREA NITROGEN | UREA | ||
40 | 00628063400959 | 153-50 | 153-50 | JMO | Ferrozine (colorimetric) iron binding capacity | 1 | UIBC-SL | |
41 | 00628063400942 | 153-30 | 153-30 | JMO | Ferrozine (colorimetric) iron binding capacity | 1 | UIBC-SL | |
42 | 00628063400904 | 236-99 | 236-99 | CDT | LIPASE HYDROLYSIS/GLYCEROL KINASE ENZYME, TRIGLYCERIDES | 1 | TRIGLYCERIDE-SL | |
43 | 00628063400898 | 236-60 | 236-60 | CDT | LIPASE HYDROLYSIS/GLYCEROL KINASE ENZYME, TRIGLYCERIDES | TRIGLYCERIDE-SL | ||
44 | 00628063400836 | SE-252 | SE-252 | JIX | CALIBRATOR, MULTI-ANALYTE MIXTURE | 2 | MICROALBUMIN Calibrators | |
45 | 00628063400744 | 80-5666-02 | 80-5666-02 | JIS | CALIBRATOR, PRIMARY | N-geneous LDL-ST Cholesterol Calibrator | ||
46 | 00628063400492 | 273-30 | 273-30 | DIC | ALCOHOL DEHYDROGENASE, SPECIFIC REAGENT FOR ETHANOL ENZYME METHOD | 2 | ETHANOL L3K Assasy | |
47 | 00742860100406 | 1034 | PSZ | Devices Detecting Influenza A, B, And C Virus Antigens | 2 | OSOM ULTRA PLUS FLU A&B Control Kit | ||
48 | 00742860100345 | 1031 | PSZ | Devices Detecting Influenza A, B, And C Virus Antigens | 2 | Acucy Calibration Device | ||
49 | 00628063400805 | 450-50 | 450-50 | CEK | BIURET (COLORIMETRIC), TOTAL PROTEIN | 2 | TOTAL PROTEIN (MICRO) Assay | |
50 | 00628063400706 | 80-4607-00 | 80-4607-00 | LBR | LDL & VLDL PRECIPITATION, HDL | 1 | N-geneous LDL Cholesterol Reagent (R2) |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00083059150155 | 1501-15 | The Biomerica Giardia test is a rapid chromatographic immunoassay for the qualit The Biomerica Giardia test is a rapid chromatographic immunoassay for the qualitative detection of Giardia antigens in human stool samples. The In Vitro test is intended for professional use only. | EZ-GIARDIA One-Step Giardia Test | BIOMERICA, INC. | |
2 | 00083059070699 | 7069 | The Biomerica Giardia ELISA is intended for the qualitative detection of Giardia The Biomerica Giardia ELISA is intended for the qualitative detection of Giardia antigen in fecal specimens. This assay is intended for research use only. | Giardia ELISA [Enzyme-Linked ImmunoSorbent Assay] | BIOMERICA, INC. | |
3 | 20885380096737 | CH6830 | CH6830 | CRYPTO GIARDIA KIT | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
4 | M445MCCCGDFA750 | MCC-C/G-DFA 75 | MCC-C/G-DFA 75 | The Para-Tect Cryptosporidium/Giardia kit is intended to detect Cryptosporidium The Para-Tect Cryptosporidium/Giardia kit is intended to detect Cryptosporidium oocysts and Giardia cysts in human stool by direct immunofluorescence microscopy. This kit contains enough reagents for 75 tests. | Para-Tect Cryptosporidium/Giardia Direct Fluorescence Assay | MEDICAL CHEMICAL CORPORATION |
5 | 08305901501154 | 1501-15 | The Biomerica Giardia test is a rapid chromatographic immunoassay for the qualit The Biomerica Giardia test is a rapid chromatographic immunoassay for the qualitative detection of Giardia antigens in human stool samples. The In Vitro test is intended for professional use only. | EZ-GIARDIA One-Step Giardia Test | BIOMERICA, INC. | |
6 | 08305900070699 | 7069 | The Biomerica Giardia ELISA is intended for the qualitative detection of Giardia The Biomerica Giardia ELISA is intended for the qualitative detection of Giardia antigen in fecal specimens. This assay is intended for research use only. | Giardia ELISA [Enzyme-Linked ImmunoSorbent Assay] | BIOMERICA, INC. | |
7 | 05391516746335 | 1206611 | 1206611 | Uni-Gold™ Giardia Control, Giardia Positive and Negative Control, 1 Positive and Uni-Gold™ Giardia Control, Giardia Positive and Negative Control, 1 Positive and 1 Negative | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
8 | 05391516746328 | 1206610 | 1206610 | Uni-Gold™ Giardia, 20 Tests | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
9 | 00893038002180 | 96100 | 96100 | Triage® Micro Parasite Panel | Triage® | ALERE SAN DIEGO, INC. |
10 | 00857031002547 | T5032 | The TECHLAB® TRl-COMBO PARASITE SCREEN test is an enzyme immunoassay for the sim The TECHLAB® TRl-COMBO PARASITE SCREEN test is an enzyme immunoassay for the simultaneous qualitative detection of Giardia spp., Cryptosporidium spp. and/or E. histolytica antigen in human fecal specimens. The test is indicated as an aid in the diagnosis of gastrointestinal infection when giardiasis, cryptosporidiosis and amebiasis is suspected. The test does not differentiate between the three parasites and follow-up testing is required for all positive results to confirm the specific diagnosis. | TRI-COMBO PARASITE SCREEN | TECHLAB, INC. | |
11 | 00857031002400 | T30408 | The TECHLAB® TRl-COMBO PARASITE SCREEN test is an enzyme immunoassay for the sim The TECHLAB® TRl-COMBO PARASITE SCREEN test is an enzyme immunoassay for the simultaneous qualitative detection of Giardia spp., Cryptosporidium spp. and/or E. histolytica antigen in human fecal specimens. The test is indicated as an aid in the diagnosis of gastrointestinal infection when giardiasis, cryptosporidiosis and amebiasis is suspected. The test does not differentiate between the three parasites and follow-up testing is required for all positive results to confirm the specific diagnosis. | TRI-COMBO PARASITE SCREEN | TECHLAB, INC. | |
12 | 00857031002295 | PT5012 | The GIARDIA II test is an enzyme immunoassay for the qualitative detection of Gi The GIARDIA II test is an enzyme immunoassay for the qualitative detection of Giardia lamblia cyst antigen in human fecal specimens. It is indicated for use with fecal specimens from patients with diarrhea to determine the presence of G. lamblia gastrointestinal infection. This test can be used for fecal specimens submitted for routine clinical testing from adults or children. | GIARDIA II | TECHLAB, INC. | |
13 | 00857031002165 | T30407 | The GIARDIA/CRYPTOSPORIDIUM QUIK CHEK™ test is a rapid membrane enzyme immunoass The GIARDIA/CRYPTOSPORIDIUM QUIK CHEK™ test is a rapid membrane enzyme immunoassay for the simultaneous qualitative detection and differentiation of Giardia cyst antigen and Cryptosporidium oocyst antigen in a single test device. It is intended for use with human fecal specimens from patients with gastrointestinal symptoms to aid in the diagnosis of Giardia and/or Cryptosporidium gastrointestinal infection. The test results should be considered in conjunction with the patient history. | GIARDIA/CRYPTOSPORIDIUM QUIK CHEK | TECHLAB, INC. | |
14 | 00857031002028 | 30405 | The GIARDIA II test is an enzyme immunoassay for the qualitative detection of Gi The GIARDIA II test is an enzyme immunoassay for the qualitative detection of Giardia lamblia cyst antigen in human fecal specimens. It is indicated for use with fecal specimens from patients with diarrhea to determine the presence of G. lamblia gastrointestinal infection. This test can be used for fecal specimens submitted for routine clinical testing from adults or children. | GIARDIA II | TECHLAB, INC. | |
15 | 00848838027017 | R2458596 | NA | OXOID LIMITED | ||
16 | 00848838027000 | R2458496 | NA | OXOID LIMITED | ||
17 | 00848838026997 | R2458096 | NA | OXOID LIMITED | ||
18 | 00848838026881 | R2450530 | NA | REMEL, INC. | ||
19 | 00848838026874 | R2450520 | Xpect Giardia/Crypto KT/20TST | NA | REMEL, INC. | |
20 | 00848838026867 | R2450030 | NA | REMEL, INC. | ||
21 | 00848838026850 | R2450020 | Xpect Giardia KT/20TST | NA | REMEL, INC. | |
22 | 00840733101113 | 250050 | 250050 | MERIFLUOR Cryptosporidium/Giardia (MERIFLUOR C/G) is an in vitro direct immunofl MERIFLUOR Cryptosporidium/Giardia (MERIFLUOR C/G) is an in vitro direct immunofluorescent detection procedure for the simultaneous detection of Cryptosporidium oocysts and Giardia cysts in fecal material. | MERIFLUOR Cryptosporidium/Giardia | MERIDIAN BIOSCIENCE, INC. |
23 | 00742860100017 | 750830 | 750830 | ImmunoStat G/C 30 Test Kit | SEKISUI DIAGNOSTICS, LLC | |
24 | 00613647000304 | 23-200-277 | 23200277 | Sure-Vue Signature Cryptosporidium and Giardia Test Kit | Sure-Vue | FISHER SCIENTIFIC COMPANY L.L.C. |