No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00848838097454 | R01822A | JSO | Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar | NA | |||
2 | 00848838065262 | R2468936 | KTN | System, Test, Infectious Mononucleosis | NA | |||
3 | 00848838023835 | R21526 | JIO | Blood, Occult, Colorimetric, In Urine | NA | |||
4 | 00848838023743 | R21502 | JFO | Fluorometric, Calcium | NA | |||
5 | 00848838093975 | R01196 | JSO | Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar | NA | |||
6 | 00848838093333 | R01187 | JSO | Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar | NA | |||
7 | 00848838091834 | 7116-70 | MYCO PZA KIT | MJA | Susceptibility Test Powders, Antimycobacterial | 2 | NA | |
8 | 00848838091827 | 7115-60 | VERSATREK MYCO SUSCEPTIBILITY KIT | MDB | System, Blood Culturing | 1 | NA | |
9 | 00848838091711 | 7114-42 | VERSATREK MYCO AS, 5/BX | MDB | System, Blood Culturing | 1 | NA | |
10 | 00848838091704 | 7113-42 | VERSATREK MYCO PVNA, 5/BX | MDB | System, Blood Culturing | 1 | NA | |
11 | 00848838091698 | 7111-42M | VERSATREK MYCO BOTTLES, W/MODIFIED CAP | MDB | System, Blood Culturing | 1 | NA | |
12 | 00848838091551 | T3462-10 | JWY | Manual Antimicrobial Susceptibility Test Systems | NA | |||
13 | 00848838091452 | 7106-44 | VERSATREK REDOX 1, 40 ML W/STIR BAR | MDB | System, Blood Culturing | 1 | NA | |
14 | 00848838091445 | 7107-44 | VERSATREK REDOX 2, EZ DRAW 40ML | MDB | System, Blood Culturing | 1 | NA | |
15 | 00848838091438 | 7110-44 | VERSATREK REDOX 2M, EZ DRAW 40ML | MDB | System, Blood Culturing | 1 | NA | |
16 | 00848838091346 | T3462-05-10 | JTZ | Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth | NA | |||
17 | 00848838091124 | 7112-42 | VERSATREK MYCO GS | MDB | System, Blood Culturing | 1 | NA | |
18 | 00848838091070 | 7103-44 | VERSATREK REDOX 2, 80ML | MDB | System, Blood Culturing | 1 | NA | |
19 | 00848838091063 | 7102-44 | VERSATREK REDOX 1, 80 ML W/STIR BAR | MDB | System, Blood Culturing | 1 | NA | |
20 | 00848838091056 | 7111-42 | VERSATREK MYCO BOTTLES | MDB | System, Blood Culturing | 1 | NA | |
21 | 00848838080913 | R30851502 | GMD | Antisera, Latex Agglutination, Cryptococcus Neoformans | 2 | NA | ||
22 | 00848838079160 | R01832 | JSO | Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar | NA | |||
23 | 00848838077135 | R01173 | JSO | Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar | NA | |||
24 | 00848838076824 | R01830 | JSO | Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar | NA | |||
25 | 00848838076817 | DR0780M | KTN | System, Test, Infectious Mononucleosis | 2 | NA | ||
26 | 00848838069826 | R01821 | JSO | Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar | NA | |||
27 | 00848838069819 | R01822 | JSO | Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar | NA | |||
28 | 00848838065385 | R2471088 | KTN | System, Test, Infectious Mononucleosis | NA | |||
29 | 00848838065279 | R2468944 | KTN | System, Test, Infectious Mononucleosis | NA | |||
30 | 00848838031601 | R421022 | KTN | System, Test, Infectious Mononucleosis | NA | |||
31 | 00848838031588 | R421021 | KTN | System, Test, Infectious Mononucleosis | NA | |||
32 | 00848838028793 | R30851501 | Cryptococcus LTX Antigen Test 50TST/KT | GMD | Antisera, Latex Agglutination, Cryptococcus Neoformans | NA | ||
33 | 00848838026904 | R2451030 | MHJ | Cryptosporidium Spp. | 2 | NA | ||
34 | 00848838026881 | R2450530 | MHI | Giardia Spp. | 2 | NA | ||
35 | 00848838026874 | R2450520 | Xpect Giardia/Crypto KT/20TST | MHI | Giardia Spp. | NA | ||
36 | 00848838026867 | R2450030 | MHI | Giardia Spp. | 2 | NA | ||
37 | 00848838026850 | R2450020 | Xpect Giardia KT/20TST | MHI | Giardia Spp. | NA | ||
38 | 00848838022371 | R21090 | MJD | Culture Media, Antimycobacteria, Susceptibility Test | NA | |||
39 | 00848838018923 | T3470 | JWY | Manual Antimicrobial Susceptibility Test Systems | NA | |||
40 | 00848838018855 | CP114-10 | JWY | Manual Antimicrobial Susceptibility Test Systems | NA | |||
41 | 00848838018831 | CP112-10 | JWY | Manual Antimicrobial Susceptibility Test Systems | NA | |||
42 | 00848838018817 | Y3462 | NGZ | Susceptibility Test Plate, Antifungal | NA | |||
43 | 00848838014369 | R10325 | JTY | Culture Media, For Isolation Of Pathogenic Neisseria | NA | |||
44 | 00848838014345 | R10320 | JTY | Culture Media, For Isolation Of Pathogenic Neisseria | NA | |||
45 | 00848838014338 | R10312 | JTY | Culture Media, For Isolation Of Pathogenic Neisseria | NA | |||
46 | 00848838014321 | R10310 | JTY | Culture Media, For Isolation Of Pathogenic Neisseria | NA | |||
47 | 00848838014123 | R10211 | JTY | Culture Media, For Isolation Of Pathogenic Neisseria | NA | |||
48 | 00848838014116 | R10210 | JTY | Culture Media, For Isolation Of Pathogenic Neisseria | NA | |||
49 | 00848838013270 | R09592 | JTZ | Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth | NA | |||
50 | 00848838011542 | R07681 | JSO | Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar | NA |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 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 |
2 | 08305900070637 | 7063 | The Biomerica Cryptosporidium ELISA is intended for the qualitative detection of The Biomerica Cryptosporidium ELISA is intended for the qualitative detection of Cryptosporidium-specific antigen (CSA) in fecal specimens. This assay is intended for in vitro diagnostic use only. | Cryptosporidium ELISA [Enzyme-Linked ImmunoSorbent Assay] | BIOMERICA, INC. | |
3 | 05391516746359 | 1206621 | 1206621 | Uni-Gold™ Cryptosporidium Control, Cryptosporidium Positive and Negative Control Uni-Gold™ Cryptosporidium Control, Cryptosporidium Positive and Negative Control, 1 Positive and 1 Negative | Trinity Biotech | MARDX DIAGNOSTICS, INC. |
4 | 05391516746342 | 1206620 | 1206620 | Uni-Gold™ Cryptosporidium, 20 Tests | TrinityBiotech | MARDX DIAGNOSTICS, INC. |
5 | 00893038002180 | 96100 | 96100 | Triage® Micro Parasite Panel | Triage® | ALERE SAN DIEGO, INC. |
6 | 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. | |
7 | 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. | |
8 | 00857031002301 | PT5014 | The CRYPTOSPORIDIUM II test is an enzyme immunoassay for the qualitative detecti The CRYPTOSPORIDIUM II test is an enzyme immunoassay for the qualitative detection of Cryptosporidium oocyst antigen in human fecal specimens. It is indicated for use as an aid in the diagnosis of patients with diarrhea suspected of Cryptosporidium gastrointestinal infection. | CRYPTOSPORIDIUM II | TECHLAB, INC. | |
9 | 00857031002240 | T5031 | The GIARDIA/CRYPTOSPORIDIUM CHEK test is an enzyme immunoassay for the qualitati The GIARDIA/CRYPTOSPORIDIUM CHEK test is an enzyme immunoassay for the qualitative detection of Giardia cyst and Cryptosporidium oocyst antigen in human fecal specimens. It is indicated for use as an aid in the diagnosis of patients with diarrhea suspected of Giardia and/or Cryptosporidium gastrointestinal infections. | GIARDIA/CRYPTOSPORIDIUM CHEK | TECHLAB, INC. | |
10 | 00857031002127 | 30401 | The GIARDIA/CRYPTOSPORIDIUM CHEK test is an enzyme immunoassay for the qualitati The GIARDIA/CRYPTOSPORIDIUM CHEK test is an enzyme immunoassay for the qualitative detection of Giardia cyst and Cryptosporidium oocyst antigen in human fecal specimens. It is indicated for use as an aid in the diagnosis of patients with diarrhea suspected of Giardia and/or Cryptosporidium gastrointestinal infections. | GIARDIA/CRYPTOSPORIDIUM CHEK | TECHLAB, INC. | |
11 | 00857031002035 | 30406 | The CRYPTOSPORIDIUM II test is an enzyme immunoassay for the qualitative detecti The CRYPTOSPORIDIUM II test is an enzyme immunoassay for the qualitative detection of Cryptosporidium oocyst antigen in human fecal specimens. It is indicated for use as an aid in the diagnosis of patients with diarrhea suspected of Cryptosporidium gastrointestinal infection. | CRYPTOSPORIDIUM II | TECHLAB, INC. | |
12 | 00848838026935 | R2454096 | NA | OXOID LIMITED | ||
13 | 00848838026904 | R2451030 | NA | REMEL, INC. | ||
14 | 00848838026898 | R2451020 | Xpect Cryptosporidium KT/20TST | NA | REMEL, INC. | |
15 | 00083059070637 | 7063 | The Biomerica Cryptosporidium ELISA is intended for the qualitative detection of The Biomerica Cryptosporidium ELISA is intended for the qualitative detection of Cryptosporidium-specific antigen (CSA) in fecal specimens. This assay is intended for in vitro diagnostic use only. | Cryptosporidium ELISA [Enzyme-Linked ImmunoSorbent Assay] | BIOMERICA, INC. |