No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 05391516749473 | Tri-stat 2 Analyzer | 03-06-0002 | Tri-stat 2 Analyzer | LCP | Assay, Glycosylated Hemoglobin | 2 | Trinity Biotech |
2 | 05391516748636 | PDQ Wash Reagent | 01-03-0067 | Hemoglobin A1c assay, PDQ Wash Reagent | LCP | Assay, Glycosylated Hemoglobin | 2 | Trinity Biotech |
3 | 05391516748629 | PDQ Diluent Reagent - 940mL | 01-03-0066 | Hemoglobin A1c assay, PDQ Diluent Reagent - 940mL | LCP | Assay, Glycosylated Hemoglobin | 2 | Trinity Biotech |
4 | 05391516748612 | PDQ 2 Reagent - 940mL | 01-03-0065 | Hemoglobin A1c assay, PDQ 2 Reagent - 940mL | LCP | Assay, Glycosylated Hemoglobin | 2 | Trinity Biotech |
5 | 05391516748605 | PDQ1 Reagent - 940mL | 01-03-0064 | Hemoglobin A1c assay, PDQ1 Reagent - 940mL | LCP | Assay, Glycosylated Hemoglobin | 2 | Trinity Biotech |
6 | 05391516744232 | Mobile Phase 1 Reagent - 3.8L | 01-03-0040 | Hemoglobin variants assay, Mobile Phase 1 Reagent - 3.8L | GKA | Abnormal Hemoglobin Quantitation | 2 | Trinity Biotech |
7 | 05391516748322 | Premier Resolution A2+F Control Material Kit | 01-04-0045 | Hemoglobin variants assay, Premier Resolution A2+F Control Material Kit | JCM | Control, Hemoglobin, Abnormal | 2 | Trinity Biotech |
8 | 05391516748315 | Premier Resolution A2+F Calibrator Kit | 01-04-0044 | Hemoglobin variants assay, Premier Resolution A2+F Calibrator Kit | JCM | Control, Hemoglobin, Abnormal | 2 | Trinity Biotech |
9 | 05391516748223 | Tri-stat Reagent Kit | 03-06-0010 | Hemoglobin A1c assay, Tri-stat Reagent Kit | LCP | Assay, Glycosylated Hemoglobin | 2 | Trinity Biotech |
10 | 05391516748216 | Tri-stat Liquid Controls Kit | 03-06-0011 | Hemoglobin A1c assay, Tri-stat Liquid Controls Kit | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Trinity Biotech |
11 | 05391516748193 | Genesys Diluent Reagent - 3.8L | 01-03-0019 | Hemoglobin variants assay, Genesys Diluent Reagent - 3.8L | GKA | Abnormal Hemoglobin Quantitation | 2 | Trinity Biotech |
12 | 05391516748186 | Ultra2 Resolution 500 | 01-04-0078 | Hemoglobin variants assay, Ultra2 Resolution 500 kit | GKA | Abnormal Hemoglobin Quantitation | 2 | Trinity Biotech |
13 | 05391516748179 | Ultra2 Resolution Variants Analyzer | 03-01-0053 | Hemoglobin variants assay, Ultra2 Resolution Variants Analyzer | GKA | Abnormal Hemoglobin Quantitation | 2 | Trinity Biotech |
14 | 05391516748162 | Ultra2 Affinity A1c 3000 | 01-04-0080 | Hemoglobin A1c assay, Ultra2 Affinity A1c 3000 | LCP | Assay, Glycosylated Hemoglobin | 2 | Trinity Biotech |
15 | 05391516748155 | Ultra2 Affinity HbA1c Analyzer (110V) | 03-01-0052 | Hemoglobin A1c assay, Ultra2 Affinity HbA1c Analyzer (110V) | LCP | Assay, Glycosylated Hemoglobin | 2 | Trinity Biotech |
16 | 05391516748148 | Premier Affinity A1c 3000 - 1 kit | 09-03-0007 | Hemoglobin A1c assay, Premier Affinity A1c 3000 - 1 kit | LCP | Assay, Glycosylated Hemoglobin | 2 | Trinity Biotech |
17 | 05391516748131 | Premier Affinity A1c 1000 - 1 kit | 09-03-0010 | Hemoglobin A1c assay, Premier Affinity A1c 1000 - 1 kit | LCP | Assay, Glycosylated Hemoglobin | 2 | Trinity Biotech |
18 | 05391516748124 | Premier Affinity A1c 500 - 1 kit | 09-03-0008 | Hemoglobin A1c assay, Premier Affinity A1c 500 - 1 kit | LCP | Assay, Glycosylated Hemoglobin | 2 | Trinity Biotech |
19 | 05391516748117 | Premier Sample Diluent Reagent - 940mL | 01-03-0101 | Hemoglobin A1c assay, Premier Sample Diluent Reagent - 940mL | LCP | Assay, Glycosylated Hemoglobin | 2 | Trinity Biotech |
20 | 05391516748100 | Premier Buffer B Reagent - 3.8L | 01-03-0081 | Hemoglobin A1c assay, Premier Buffer B Reagent - 3.8L | LCP | Assay, Glycosylated Hemoglobin | 2 | Trinity Biotech |
21 | 05391516748094 | Premier Buffer A Reagent - 3.8L | 01-03-0080 | Hemoglobin A1c assay, Premier Buffer A Reagent - 3.8L | LCP | Assay, Glycosylated Hemoglobin | 2 | Trinity Biotech |
22 | 05391516748070 | HbA1c (GHb) Calibrator Kit, 500uL (Levels 1 & 2) - 1 kit | 01-04-0022 | Hemoglobin A1c assay, HbA1c (GHb) Calibrator Kit, 500uL (Levels 1 & 2) - 1 kit | JPK | Mixture, Hematology Quality Control | 2 | Trinity Biotech |
23 | 05391516748063 | Premier Hb9210 HbA1c Analytical Column (500) | 09-06-0050 | Hemoglobin A1c assay, Premier Hb9210 HbA1c Analytical Column (500) | LCP | Assay, Glycosylated Hemoglobin | 2 | Trinity Biotech |
24 | 05391516748056 | Premier Hb9210 HbA1c Analytical Column (1000) | 09-06-0046 | Hemoglobin A1c assay, Premier Hb9210 HbA1c Analytical Column (1000) | LCP | Assay, Glycosylated Hemoglobin | 2 | Trinity Biotech |
25 | 05391516744812 | HbA1c (GHb) Calibrator Kit, 400uL (Levels 1 & 2) - 1 kit | 01-04-0018 | Hemoglobin A1c assay, HbA1c (GHb) Calibrator Kit, 400uL (Levels 1 & 2) - 1 kit | JPK | Mixture, Hematology Quality Control | 2 | Trinity Biotech |
26 | 05391516744799 | Premier Wash Reagent - 940mL | 01-03-0098 | Hemoglobin A1c assay, Premier Wash Reagent - 940mL | LCP | Assay, Glycosylated Hemoglobin | 2 | Trinity Biotech |
27 | 05391516744782 | Premier Diluent Reagent - 3.8L | 01-03-0097 | Hemoglobin A1c assay, Premier Diluent Reagent - 3.8L | LCP | Assay, Glycosylated Hemoglobin | 2 | Trinity Biotech |
28 | 05391516744775 | Premier Buffer B Reagent - 940mL | 01-03-0096 | Hemoglobin A1c assay, Premier Buffer B Reagent - 940mL | LCP | Assay, Glycosylated Hemoglobin | 2 | Trinity Biotech |
29 | 05391516744768 | Premier Buffer A Reagent - 940mL | 01-03-0095 | Hemoglobin A1c assay, Premier Buffer A Reagent - 940mL | LCP | Assay, Glycosylated Hemoglobin | 2 | Trinity Biotech |
30 | 05391516744751 | Premier Hb9210 HbA1c Analyzer - 1 each | 09-00-0001 | Hemoglobin A1c assay, Premier Hb9210 HbA1c Analyzer | LCP | Assay, Glycosylated Hemoglobin | 2 | Trinity Biotech |
31 | 05391516744553 | Affinity Analytical Column | 03-02-0079 | Hemoglobin A1c assay, Affinity Analytical Column | LCP | Assay, Glycosylated Hemoglobin | 2 | Trinity Biotech |
32 | 05391516744546 | Enzyme Cleaner Tube | 01-12-0001 | Hemoglobin A1c assay, Enzyme Cleaner Tube | LCP | Assay, Glycosylated Hemoglobin | 2 | Trinity Biotech |
33 | 05391516744539 | Genesys Analytical Column | 01-05-0017 | Hemoglobin variants assay, Genesys Analytical Column | GKA | Abnormal Hemoglobin Quantitation | 2 | Trinity Biotech |
34 | 05391516744522 | Resolution Analytical Column | 01-05-0015 | Hemoglobin variants assay, Resolution Analytical Column | GKA | Abnormal Hemoglobin Quantitation | 2 | Trinity Biotech |
35 | 05391516744409 | A2+F Control Material Kit | 01-04-0043 | Hemoglobin variants assay, A2+F Control Material Kit | JCM | Control, Hemoglobin, Abnormal | 2 | Trinity Biotech |
36 | 05391516744393 | FASC Position Marker Kit | 01-04-0042 | Hemoglobin variants assay, FASC Position Marker Kit | JCM | Control, Hemoglobin, Abnormal | 2 | Trinity Biotech |
37 | 05391516744379 | HbA1c (GHb) Controls Kit, 400uL (Levels I & II) - 1 kit | 01-04-0015 | Hemoglobin A1c assay, HbA1c (GHb) Controls Kit, 400uL (Levels I & II) - 1 kit | JPK | Mixture, Hematology Quality Control | 2 | Trinity Biotech |
38 | 05391516744317 | 2 Diluent Reagent - 940mL | 01-03-0059 | Hemoglobin A1c assay, 2 Diluent Reagent - 940mL | LCP | Assay, Glycosylated Hemoglobin | 2 | Trinity Biotech |
39 | 05391516744294 | 2 Diluent Reagent - 3.8L | 01-03-0058 | Hemoglobin A1c assay, 2 Diluent Reagent - 3.8L | LCP | Assay, Glycosylated Hemoglobin | 2 | Trinity Biotech |
40 | 05391516744287 | Ultra2 Buffer 2A Reagent - 3.8L | 01-03-0054 | Hemoglobin A1c assay, Ultra2 Buffer 2A Reagent - 3.8L | LCP | Assay, Glycosylated Hemoglobin | 2 | Trinity Biotech |
41 | 05391516744270 | Ultra2 Buffer 2A Reagent - 940mL | 01-03-0053 | Hemoglobin A1c assay, Ultra2 Buffer 2A Reagent - 940mL | LCP | Assay, Glycosylated Hemoglobin | 2 | Trinity Biotech |
42 | 05391516744263 | Mobile Phase 2 Reagent - 940mL | 01-03-0044 | Hemoglobin variants assay, Mobile Phase 2 Reagent - 940mL | GKA | Abnormal Hemoglobin Quantitation | 2 | Trinity Biotech |
43 | 05391516744256 | Mobile Phase 1 Reagent - 940mL | 01-03-0042 | Hemoglobin variants assay, Mobile Phase 1 Reagent - 940mL | GKA | Abnormal Hemoglobin Quantitation | 2 | Trinity Biotech |
44 | 05391516744249 | Mobile Phase 2 Reagent - 3.8L | 01-03-0041 | Hemoglobin variants assay, Mobile Phase 2 Reagent - 3.8L | GKA | Abnormal Hemoglobin Quantitation | 2 | Trinity Biotech |
45 | 05391516744218 | System Wash Reagent - 940mL | 01-03-0035 | Hemoglobin A1c assay, System Wash Reagent - 940mL | LCP | Assay, Glycosylated Hemoglobin | 2 | Trinity Biotech |
46 | 05391516744201 | Genesys 2 Reagent - 3.8L | 01-03-0022 | Hemoglobin variants assay, Genesys 2 Reagent - 3.8L | GKA | Abnormal Hemoglobin Quantitation | 2 | Trinity Biotech |
47 | 05391516744195 | Genesys 1 Reagent - 3.8L | 01-03-0020 | Hemoglobin variants assay, Genesys 1 Reagent - 3.8L | GKA | Abnormal Hemoglobin Quantitation | 2 | Trinity Biotech |
48 | 05391516744171 | Ultra2 Buffer B Reagent - 3.8L | 01-03-0012 | Hemoglobin A1c assay, Ultra2 Buffer B Reagent - 3.8L | LCP | Assay, Glycosylated Hemoglobin | 2 | Trinity Biotech |
49 | 05391516744164 | Ultra2 Buffer B Reagent - 940mL | 01-03-0011 | Hemoglobin A1c assay, Ultra2 Buffer B Reagent - 940mL | LCP | Assay, Glycosylated Hemoglobin | 2 | Trinity Biotech |
50 | 05391516744126 | Ultra2 Affinity HbA1c Analyzer (220V) | 03-01-0048 | Hemoglobin A1c assay, Ultra2 Affinity HbA1c Analyzer (220V) | LCP | Assay, Glycosylated Hemoglobin | 2 | Trinity Biotech |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 08718734960515 | 250.002.002 | 250.002.002 | Assayed Quality control solution | Eurotrol | EUROTROL B.V. |
2 | 08718734960492 | 250.001.002 | 250.001.002 | Assayed Quality control solution | Eurotrol | EUROTROL B.V. |
3 | 06944904084169 | BC-5D | BC-5D Control | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. | ||
4 | 06944904084145 | BC-3D | BC-3D Control | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. | ||
5 | 05391516748087 | HbA1c (GHb) Controls Kit, 500uL (Levels I & II) - 1 kit | 01-04-0020 | Hemoglobin A1c assay, HbA1c (GHb) Controls Kit, 500uL (Levels I & II) - 1 kit | Trinity Biotech | PRIMUS CORPORATION |
6 | 05391516748070 | HbA1c (GHb) Calibrator Kit, 500uL (Levels 1 & 2) - 1 kit | 01-04-0022 | Hemoglobin A1c assay, HbA1c (GHb) Calibrator Kit, 500uL (Levels 1 & 2) - 1 kit | Trinity Biotech | PRIMUS CORPORATION |
7 | 05391516744812 | HbA1c (GHb) Calibrator Kit, 400uL (Levels 1 & 2) - 1 kit | 01-04-0018 | Hemoglobin A1c assay, HbA1c (GHb) Calibrator Kit, 400uL (Levels 1 & 2) - 1 kit | Trinity Biotech | PRIMUS CORPORATION |
8 | 05391516744379 | HbA1c (GHb) Controls Kit, 400uL (Levels I & II) - 1 kit | 01-04-0015 | Hemoglobin A1c assay, HbA1c (GHb) Controls Kit, 400uL (Levels I & II) - 1 kit | Trinity Biotech | PRIMUS CORPORATION |
9 | 05055273215632 | HM10192 | HAEMATOLOGY CONTROL - LEVEL 3 (HAEM CNTL - LEVEL 3) | RANDOX LABORATORIES LIMITED | ||
10 | 05055273215625 | HM10191 | HAEMATOLOGY CONTROL - LEVEL 2 (HAEM CNTL - LEVEL 2) | RANDOX LABORATORIES LIMITED | ||
11 | 05055273215618 | HM10190 | HAEMATOLOGY CONTROL - LEVEL 1 (HAEM CNTL - LEVEL 1) | RANDOX LABORATORIES LIMITED | ||
12 | 05055273210200 | HM5162 | HM5162 | This product is intended for in vitro diagnostic use in the quality control of m This product is intended for in vitro diagnostic use in the quality control of multiple haematology parameters | HAEM CNTL - LEVEL 1, 2, 3 | RANDOX LABORATORIES LIMITED |
13 | 00896863002097 | 1462-31 | 1462-31 | Spinalscopics Spinal Fluid Cell Count Control is intended for monitoring total c Spinalscopics Spinal Fluid Cell Count Control is intended for monitoring total cell counts performed manually using a hemocytometer to validate quantitation of red and white blood cells in patient CSF samples. Total cell counts are performed in a counting chamber with undiluted CSF. They are supplied in two levels, 3x3mL bottles per level per box. The controls are ready-to-use liquid, requiring no reconstitution or dilution. They are prepared in a human protein matrix fortified to target levels with purified chemicals and stabilized human red and white blood cells. Preservatives have been added to inhibit microbial growth. | Spinalscopics Control Level 2 Set 3x3mL | QUANTIMETRIX CORPORATION |
14 | 00896863002080 | 1461-31 | 1461-31 | Spinalscopics Spinal Fluid Cell Count Control is intended for monitoring total c Spinalscopics Spinal Fluid Cell Count Control is intended for monitoring total cell counts performed manually using a hemocytometer to validate quantitation of red and white blood cells in patient CSF samples. Total cell counts are performed in a counting chamber with undiluted CSF. They are supplied in two levels, 3x3mL bottles per level per box. The controls are ready-to-use liquid, requiring no reconstitution or dilution. They are prepared in a human protein matrix fortified to target levels with purified chemicals and stabilized human red and white blood cells. Preservatives have been added to inhibit microbial growth. | Spinalscopics Control Level 1 Set 3x3mL | QUANTIMETRIX CORPORATION |
15 | 00884883005860 | HYC84669 | Hema-Trol | MICROGENICS CORPORATION | ||
16 | 00884883005853 | HYC84668 | Hema-Trol | MICROGENICS CORPORATION | ||
17 | 00884883005846 | HYC84667 | Hema-Trol | MICROGENICS CORPORATION | ||
18 | 00884883005839 | HYC84666 | Hema-Trol | MICROGENICS CORPORATION | ||
19 | 00858092006543 | 424305 | 424305 | QBC Extended Range Hematology Controls | QBC Diagnostics | DRUCKER DIAGNOSTICS |
20 | 00858092006277 | 424304 | 424304 | QBC Hematology Controls | QBC Diagnostics | DRUCKER DIAGNOSTICS |
21 | 00856605006134 | 2x2.5mL High | 5302042207 | Whole Blood Hematology Control | MINOTROL CRP | HORIBA INSTRUMENTS INCORPORATED |
22 | 00856605006127 | 2x2.5mL Normal | 5302042206 | Whole Blood Hematology Control | MINOTROL CRP | HORIBA INSTRUMENTS INCORPORATED |
23 | 00856605006110 | 2x2.5mL Low | 5302042205 | Whole Blood Hematology Control | MINOTROL CRP | HORIBA INSTRUMENTS INCORPORATED |
24 | 00856605006097 | 24x3 mL | 5300100147 | Whole Blood Hematology Control | DIFFTROL | HORIBA INSTRUMENTS INCORPORATED |
25 | 00856605006080 | 12x3 mL | 5300100142 | Whole Blood Hematology Control | DIFFTROL | HORIBA INSTRUMENTS INCORPORATED |
26 | 00856605006073 | 6x3 mL | 5300100141 | Whole Blood Hematology Control | DIFFTROL | HORIBA INSTRUMENTS INCORPORATED |
27 | 00856605006066 | 3x3 mL | 5300100112 | Whole Blood Hematology Control | DIFFTROL | HORIBA INSTRUMENTS INCORPORATED |
28 | 00856605006059 | 12x3mL | 5300100075 | Whole Blood Hematology Control | MINOTROL RETIC | HORIBA INSTRUMENTS INCORPORATED |
29 | 00856605006042 | 3x3mL | 5300000284 | Whole Blood Hematology Control | MINOTROL RETIC | HORIBA INSTRUMENTS INCORPORATED |
30 | 00856605006035 | 12x2.5mL | 5300000283 | Whole Blood Hematology Control | MINOTROL 16 | HORIBA INSTRUMENTS INCORPORATED |
31 | 00856605006028 | 6x2.5mL | 5300000278 | Whole Blood Hematology Control | MINOTROL 16 | HORIBA INSTRUMENTS INCORPORATED |
32 | 00856605006011 | 3x2.5mL | 5300000277 | Whole Blood Hematology Control | MINOTROL 16 | HORIBA INSTRUMENTS INCORPORATED |
33 | 00847661004981 | 827X | 827X | Liquichek Reticulocyte Control (C) Trilevel MiniPak (An assayed reticulocyte control.) | Liquichek | BIO-RAD LABORATORIES, INC. |
34 | 00847661004974 | 828 | 828 | Liquichek Reticulocyte Control (C) Level 3 (An assayed reticulocyte control.) | Liquichek | BIO-RAD LABORATORIES, INC. |
35 | 00847661004967 | 827 | 827 | Liquichek Reticulocyte Control (C) Level 2 (An assayed reticulocyte control.) | Liquichek | BIO-RAD LABORATORIES, INC. |
36 | 00847661004950 | 826 | 826 | Liquichek Reticulocyte Control (C) Level 1 (An assayed reticulocyte control.) | Liquichek | BIO-RAD LABORATORIES, INC. |
37 | 00847661004943 | 144X | 144X | Liquichek Hematology-16T Control Trilevel MiniPak (An assayed hematology control.) | Liquichek | BIO-RAD LABORATORIES, INC. |
38 | 00847661004936 | 144 | 144 | Liquichek Hematology-16T Control Trilevel (An assayed hematology control.) | Liquichek | BIO-RAD LABORATORIES, INC. |
39 | 00847661004929 | 868 | 868 | Liquichek Hematology Control (A) High (An assayed hematology control.) | Liquichek | BIO-RAD LABORATORIES, INC. |
40 | 00847661004912 | 867 | 867 | Liquichek Hematology Control (A) Normal (An assayed hematology control.) | Liquichek | BIO-RAD LABORATORIES, INC. |
41 | 00847661004905 | 866 | 866 | Liquichek Hematology Control (A) Low (An assayed hematology control.) | Liquichek | BIO-RAD LABORATORIES, INC. |
42 | 00847661004899 | 865X | 865X | Liquichek Hematology Control (A) Trilevel MiniPak (An assayed hematology control.) | Liquichek | BIO-RAD LABORATORIES, INC. |
43 | 00847661004882 | 865 | 865 | Liquichek Hematology Control (A) Trilevel (An assayed hematology control.) | Liquichek | BIO-RAD LABORATORIES, INC. |
44 | 00847661004875 | 855X | 855X | Liquichek Reticulocyte Control (A) Bilevel MiniPak (An assayed reticulocyte control.) | Liquichek | BIO-RAD LABORATORIES, INC. |
45 | 00847661004868 | 855 | 855 | Liquichek Reticulocyte Control (A) Level 2 (An assayed reticulocyte control.) | Liquichek | BIO-RAD LABORATORIES, INC. |
46 | 00847661004851 | 854 | 854 | Liquichek Reticulocyte Control (A) Level 1 (An assayed reticulocyte control.) | Liquichek | BIO-RAD LABORATORIES, INC. |
47 | 00847661003878 | 927X | 927X | Liquichek Reticulocyte Control (X) Trilevel MiniPak (An assayed reticulocyte control.) | Liquichek | BIO-RAD LABORATORIES, INC. |
48 | 00847661003861 | 928 | 928 | Liquichek Reticulocyte Control (X) Level 3 (An assayed reticulocyte control.) | Liquichek | BIO-RAD LABORATORIES, INC. |
49 | 00847661003854 | 927 | 927 | Liquichek Reticulocyte Control (X) Level 2 (An assayed reticulocyte control.) | Liquichek | BIO-RAD LABORATORIES, INC. |
50 | 00847661003847 | 926 | 926 | Liquichek Reticulocyte Control (X) Level 1 (An assayed reticulocyte control.) | Liquichek | BIO-RAD LABORATORIES, INC. |