No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 08809301168073 | GT-C03 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | GlucoTrack Solution Level 3 | ||
2 | 08809301161029 | PS-004 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | Gmate® Blood Glucose Test Strips | |||
3 | 08809301160411 | PG-101 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | Gmate Smart Blood Glucose Monitoring System | ||
4 | 08809301162194 | PC001-US | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Pip Control Solution Low | ||
5 | 08809301162200 | PC002-US | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Pip Control Solution Normal | ||
6 | 08809301161036 | PS-004 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | Gmate® Blood Glucose Test Strips | |||
7 | 08809301162026 | PC-003 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Gmate® Control Solution Level 3 | ||
8 | 08809301161760 | PS-004 | NBW,CGA | System, Test, Blood Glucose, Over The Counter,Glucose Oxidase, Glucose | Pip Blood Glucose Test Strips | |||
9 | 08809301168059 | GT-C01 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | GlucoTrack Solution Level 1 | ||
10 | 08809301160152 | PG-200 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | Gmate® mini Blood Glucose Monitoring System | ||
11 | 08809301160114 | PG-200 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | Gmate® mini Blood Glucose Monitoring System | ||
12 | 08809301160015 | PG-200 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | Gmate® mini Blood Glucose Monitoring System | ||
13 | 08809301160862 | PG-310 | NBW,CGA | System, Test, Blood Glucose, Over The Counter,Glucose Oxidase, Glucose | 2 | Pip Blood Glucose Monitoring System | ||
14 | 08809301160213 | PG-301 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | Gmate® VOICE Blood Glucose Monitoring System | ||
15 | 08809301160138 | PG-301 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | Gmate® VOICE Blood Glucose Monitoring System | ||
16 | 08809301160084 | PG-301 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | Gmate® VOICE Blood Glucose Monitoring System | ||
17 | 08809301168134 | GT-101 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | GlucoTrack SMART Blood Glucose Monitoring System | ||
18 | 08809301168127 | GT-101 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | GlucoTrack SMART Blood Glucose Monitoring System | ||
19 | 08809301168110 | GT-101 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | GlucoTrack SMART Blood Glucose Monitoring System | ||
20 | 08809301162057 | PC-001 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Gmate® Control Solution Level 1 | ||
21 | 08809301162019 | PC-002 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Gmate® Control Solution Level 2 | ||
22 | 08809301168042 | GT-S01 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | GlucoTrack Blood Glucose Test Strips | |||
23 | 08809301168011 | GT-S01 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | GlucoTrack Blood Glucose Test Strips | |||
24 | 08809301160206 | PG-310 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | Gmate® Origin Blood Glucose Monitoring System | ||
25 | 08809301160145 | PG-310 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | Gmate® Origin Blood Glucose Monitoring System | ||
26 | 08809301160077 | PG-310 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | Gmate® Origin Blood Glucose Monitoring System | ||
27 | 08809301168103 | GT-301 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | GlucoTrack VOICE Blood Glucose Monitoring System | ||
28 | 08809301168097 | GT-301 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | GlucoTrack VOICE Blood Glucose Monitoring System | ||
29 | 08809301168080 | GT-301 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | GlucoTrack Voice Blood Glucose Monitoring System | ||
30 | 08809301166031 | PG-101 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | Gmate® SMART Blood Glucose Monitoring System | ||
31 | 08809301166017 | PG-101 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | Gmate® SMART Blood Glucose Monitoring System | ||
32 | 08809301166000 | PG-101 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | Gmate® SMART Blood Glucose Monitoring System | ||
33 | 08809301162217 | PC003-US | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Pip Control Solution High | ||
34 | 08809301160169 | PG-201 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | Gmate® STEP Blood Glucose Monitoring System | ||
35 | 08809301160121 | PG-201 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | Gmate® STEP Blood Glucose Monitoring System | ||
36 | 08809301160022 | PG-201 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | Gmate® STEP Blood Glucose Monitoring System |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00847865011648 | 6633740 | 6633740 | 25-OH Vitamin D Control Lot Data | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
2 | 00847865011631 | 6633730 | 6633730 | 25-OH Vitamin D Control Set | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
3 | 00847865010894 | 6632240 | 6632240 | Celiac IgG Control Lot Data | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
4 | 00847865010887 | 6632340 | 6632340 | Celiac IgA Control Lot Data | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
5 | 00847865010627 | 6632230 | 6632230 | Celiac IgG Control Set | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
6 | 00847865010610 | 6632330 | 6632330 | Celiac IgA Control Set | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
7 | 00847865001168 | 6633840 | 6633840 | Rubella & CMV IgM Control Lot Data | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
8 | 00847865001151 | 6633830 | 6633830 | Rubella & CMV Control Set | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
9 | 00847865000703 | 6632140 | 6632140 | APLS IgA Control Lot Data | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
10 | 00847865000697 | 6632130 | 6632130 | APLS IgA Control Set | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
11 | 00847865000659 | 6632040 | 6632040 | APLS IgM Control Lot Data | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
12 | 00847865000642 | 6632030 | 6632030 | APLS IgM Control Set | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
13 | 00847865000598 | 6631940 | 6631940 | APLS IgG Control Lot Data | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
14 | 00847865000581 | 6631930 | 6631930 | APLS IgG Control Set | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
15 | 00847717034009 | TRUEtrack Blood Glucose Meter Medidor de Glucosa en la Sangre | A4092-81 | Vida Mia mi salud TRUEtrack Blood Glucose Meter Medidor de Glucosa en la Sangre | TRUEtrack | TRIVIDIA HEALTH, INC. |
16 | 00847661004639 | 288X | 288X | Liquichek Homocysteine Control MiniPak (A human serum assayed homocysteine control.) | Liquichek | BIO-RAD LABORATORIES, INC. |
17 | 00847661004622 | 289 | 289 | Liquichek Homocysteine Control Level 3 (A human serum assayed homocysteine control.) | Liquichek | BIO-RAD LABORATORIES, INC. |
18 | 00847661004615 | 288 | 288 | Liquichek Homocysteine Control Level 2 (A human serum assayed homocysteine control.) | Liquichek | BIO-RAD LABORATORIES, INC. |
19 | 00847661004608 | 287 | 287 | Liquichek Homocysteine Control Level 1 (A human serum assayed homocysteine control.) | Liquichek | BIO-RAD LABORATORIES, INC. |
20 | 00847661004301 | 292X | 292X | Liquichek Diabetes Control Trilevel MiniPak (A human whole blood assayed diabete Liquichek Diabetes Control Trilevel MiniPak (A human whole blood assayed diabetes control.) | Liquichek | BIO-RAD LABORATORIES, INC. |
21 | 00847661004295 | 293 | 293 | Liquichek Diabetes Control Level 3 (A human whole blood assayed diabetes control.) | Liquichek | BIO-RAD LABORATORIES, INC. |
22 | 00847661004288 | 292 | 292 | Liquichek Diabetes Control Level 2 (A human whole blood assayed diabetes control.) | Liquichek | BIO-RAD LABORATORIES, INC. |
23 | 00847661004271 | 291 | 291 | Liquichek Diabetes Control Level 1 (A human whole blood assayed diabetes control.) | Liquichek | BIO-RAD LABORATORIES, INC. |
24 | 00847661001768 | 255X | 255X | Liquichek Elevated CRP Control MiniPak (A human serum C-Reactive Protein control.) | Liquichek | BIO-RAD LABORATORIES, INC. |
25 | 00847661000938 | 256 | 256 | Liquichek Elevated CRP Control Level 3 (A human serum C-Reactive Protein control.) | Liquichek | BIO-RAD LABORATORIES, INC. |
26 | 00847661000921 | 255 | 255 | Liquichek Elevated CRP Control Level 2 (A human serum C-Reactive Protein control.) | Liquichek | BIO-RAD LABORATORIES, INC. |
27 | 00847661000914 | 254 | 254 | Liquichek Elevated CRP Control Level 1 (A human serum C-Reactive Protein control.) | Liquichek | BIO-RAD LABORATORIES, INC. |
28 | 00844509001003 | 285536 | 285536 | A1c-Cellular Linearity contains one vial each of Levels 1-5. A1c-Cellular Linear A1c-Cellular Linearity contains one vial each of Levels 1-5. A1c-Cellular Linearity assesses the accuracy and linear reportable range of the HbA1c parameter. | A1c-Cellular Linearity | STRECK, INC. |
29 | 00844509000945 | 211130 | 211130 | A liquid control appropriate for immunoassay and ionic exchange HPLC methodologi A liquid control appropriate for immunoassay and ionic exchange HPLC methodologies. Contains one vial each of Level 1 and 2. | A1c-Cellular | STRECK, INC. |
30 | 00844509000938 | 211124 | 211124 | A liquid control appropriate for immunoassay and ionic exchange HPLC methodologi A liquid control appropriate for immunoassay and ionic exchange HPLC methodologies. Contains 3 vials each of Level 1 and 2. | A1c-Cellular | STRECK, INC. |
31 | 00842768037535 | 10707958 | KC683 | LOCI Cardiac Troponin-I Control (high), 12 vials x2.2mL | Dimension Vista® / Dimension® EXL™ LCTNI CON H | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
32 | 00842768037528 | 10707957 | KC682 | LOCI Cardiac Troponin-I Control (medium), 12 vials x2.2mL | Dimension Vista® / Dimension® EXL™ LCTNI CON M | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
33 | 00842768037511 | 10707956 | KC681 | LOCI Cardiac Troponin-I Control (low), 12 vials x2.2mL | Dimension Vista® / Dimension® EXL™ LCTNI CON L | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
34 | 00842768032615 | 10483822 | DF105A | Hemoglobin B1c Flex® reagent cartridges, HB1C Calibrator | Dimension® Flex Reagent Cartridge HB1C | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
35 | 00842768022685 | 10733022 | 10733022 | Anti-HBe2 (aHBe2) – Atellica IM – QC Kit | Atellica IM aHBe2 QC | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
36 | 00842768007248 | 10446040 | OQCW05 | Assayed control for Lp(a) assay on BN Systems | N Lp(a) Control SY | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
37 | 00842768006418 | 10445927 | KC745 | C1IN CON is an assayed, mid level, intralaboratory quality control for the asses C1IN CON is an assayed, mid level, intralaboratory quality control for the assessment of precision and analytical bias in the determination of the C1IN method on the Dimension Vista® System | DImension Vista® C1 Inhibitor Control | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
38 | 00817869020298 | SC-131EL | SC-131EL | ACE Elevated Control | ANALYTICAL CONTROL SYSTEMS INC | |
39 | 00817869020281 | SC-131 | SC-131 | ACE Normal Control | ANALYTICAL CONTROL SYSTEMS INC | |
40 | 00817439020857 | HCG-CTLB | HCG-CTLB | HCG Control Set Level B, for In Vitro Diagnostic Use. HCG Control is an unassaye HCG Control Set Level B, for In Vitro Diagnostic Use. HCG Control is an unassayed, stable, ready to use liquid, bi-level control for use with assays designed to quantitate HCG. It is intended for determining “Hook-Dose Effect” and the accuracy and precision of dilution protocols. Size: 4 x 2.5 ml | MedTest DX HCG Control Set Level B | MEDTEST DX, INC. |
41 | 00817439020840 | HCGCTLB | HCGCTLB | Elevated HCG Control Vial Label - B, For In Vitro Diagnostic Use. HCG Control is Elevated HCG Control Vial Label - B, For In Vitro Diagnostic Use. HCG Control is an unassayed, stable, ready to use liquid, bi-level control for use with assays designed to quantitate HCG. It is intended for determining “Hook-Dose Effect” and the accuracy and precision of dilution protocols. Size: 1 x 2.5 mL. | MedTest DX Elevated HCG Control Vial Label - B | MEDTEST DX, INC. |
42 | 00817439020833 | HCG-CTLA | HCG-CTLA | HCG Control Set Level A, for In Vitro Diagnostic Use. HCG Control is an unassaye HCG Control Set Level A, for In Vitro Diagnostic Use. HCG Control is an unassayed, stable, ready to use liquid, bi-level control for use with assays designed to quantitate HCG. It is intended for determining “Hook-Dose Effect” and the accuracy and precision of dilution protocols. Size: 4 x 2.5 ml | MedTest DX HCG Control Set Level A | MEDTEST DX, INC. |
43 | 00817439020826 | HCGCTLA | HCGCTLA | Elevated HCG Control Vial Label - A, for In Vitro Diagnostic Use. HCG Control is Elevated HCG Control Vial Label - A, for In Vitro Diagnostic Use. HCG Control is an unassayed, stable, ready to use liquid, bi-level control for use with assays designed to quantitate HCG. It is intended for determining “Hook-Dose Effect” and the accuracy and precision of dilution protocols. Size: 1 x 2.5 mL. | MedTest DX Elevated HCG Control Vial Label - A | MEDTEST DX, INC. |
44 | 00817439020819 | HCG-CTL | HCG-CTL | HCG Control Set, for In Vitro Diagnostic Use. HCG Control is an unassayed, stabl HCG Control Set, for In Vitro Diagnostic Use. HCG Control is an unassayed, stable, ready to use liquid, bi-level control for use with assays designed to quantitate HCG. It is intended for determining “Hook-Dose Effect” and the accuracy and precision of dilution protocols. Size: 4 x 2.5 mL. | MedTest DX HCG Control Set | MEDTEST DX, INC. |
45 | 00817302023046 | DT243 | DT243 | CREA (Creatinine) 4 x 400 tests | CAROLINA LIQUID CHEMISTRIES CORP.® CREA REAGENT PRODUCT NO. DT243 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
46 | 00817302022131 | CC612 | CC612 | FRUC (Fructosamine) w/ cal 2 x 40 tests | CAROLINA LIQUID CHEMISTRIES CORP.™ FRUC FRUCTOSAMINE CC612 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
47 | 00817302022124 | AU-612 | AU-612 | FRUC (Fructosamine) w/ cal 3 x 80 tests | CAROLINA LIQUID CHEMISTRIES CORP.® FRUC RGT. KIT AU-612 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
48 | 00817302022117 | CC030 | CC030 | FRUC (Fructosamine) Control | CAROLINA LIQUID CHEMISTRIES CORP.® FRUC CONTROL SET CC030 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
49 | 00817302020175 | ST500 | ST500 | Vitamin D-direct w/ cal 1 x 100 tests | CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 Vitamin D CONTROL SET | CAROLINA LIQUID CHEMISTRIES CORPORATION |
50 | 00817302020168 | ST501 | ST501 | Vitamin D-direct control 2 x 2 mL (2 lev) | CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 Vitamin D RGT KIT Product No. ST500 | CAROLINA LIQUID CHEMISTRIES CORPORATION |