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 | 08809301168066 | GT-C02 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | GlucoTrack Solution Level 2 | ||
18 | 08809301168134 | GT-101 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | GlucoTrack SMART Blood Glucose Monitoring System | ||
19 | 08809301168127 | GT-101 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | GlucoTrack SMART Blood Glucose Monitoring System | ||
20 | 08809301168110 | GT-101 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | GlucoTrack SMART Blood Glucose Monitoring System | ||
21 | 08809301162057 | PC-001 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Gmate® Control Solution Level 1 | ||
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 | 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. |
2 | 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. |
3 | 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. |
4 | 00842768037535 | 10707958 | KC683 | LOCI Cardiac Troponin-I Control (high), 12 vials x2.2mL | Dimension Vista® / Dimension® EXL™ LCTNI CON H | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
5 | 00842768037528 | 10707957 | KC682 | LOCI Cardiac Troponin-I Control (medium), 12 vials x2.2mL | Dimension Vista® / Dimension® EXL™ LCTNI CON M | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
6 | 00842768037511 | 10707956 | KC681 | LOCI Cardiac Troponin-I Control (low), 12 vials x2.2mL | Dimension Vista® / Dimension® EXL™ LCTNI CON L | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
7 | 00842768032615 | 10483822 | DF105A | Hemoglobin B1c Flex® reagent cartridges, HB1C Calibrator | Dimension® Flex Reagent Cartridge HB1C | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
8 | 00842768022685 | 10733022 | 10733022 | Anti-HBe2 (aHBe2) – Atellica IM – QC Kit | Atellica IM aHBe2 QC | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
9 | 00842768007248 | 10446040 | OQCW05 | Assayed control for Lp(a) assay on BN Systems | N Lp(a) Control SY | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
10 | 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 |
11 | 00817869020298 | SC-131EL | SC-131EL | ACE Elevated Control | ANALYTICAL CONTROL SYSTEMS INC | |
12 | 00817869020281 | SC-131 | SC-131 | ACE Normal Control | ANALYTICAL CONTROL SYSTEMS INC | |
13 | 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. |
14 | 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. |
15 | 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. |
16 | 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. |
17 | 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. |
18 | 00817302023046 | DT243 | DT243 | CREA (Creatinine) 4 x 400 tests | CAROLINA LIQUID CHEMISTRIES CORP.® CREA REAGENT PRODUCT NO. DT243 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
19 | 00817302022131 | CC612 | CC612 | FRUC (Fructosamine) w/ cal 2 x 40 tests | CAROLINA LIQUID CHEMISTRIES CORP.™ FRUC FRUCTOSAMINE CC612 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
20 | 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 |
21 | 00817302022117 | CC030 | CC030 | FRUC (Fructosamine) Control | CAROLINA LIQUID CHEMISTRIES CORP.® FRUC CONTROL SET CC030 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
22 | 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 |
23 | 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 |
24 | 00817302020151 | CC204-100-D | CC204-100-D | Lp(a) (Lipoprotein (a) 2 x 60 tests | CAROLINA LIQUID CHEMISTRIES CORP.™ Lp(a)-d LIPOPROTEIN A CC204-100-D | CAROLINA LIQUID CHEMISTRIES CORPORATION |
25 | 00817302020144 | AU-204-D | AU-204-D | Lp(a) (Lipoprotein (a) 3 x 400 tests | CAROLINA LIQUID CHEMISTRIES CORP.® LP(a)-D RGT. KIT AU-204-D | CAROLINA LIQUID CHEMISTRIES CORPORATION |
26 | 00817302020137 | BL204 | BL204 | Lp(a) (Lipoprotein (a) 2 x 130 tests | CAROLINA LIQUID CHEMISTRIES CORP.® LP(a) RGT. KIT BL-204 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
27 | 00817302020120 | CC202 | CC202 | HCY (Homocysteine) w/ cal 2 x 60 tests | CAROLINA LIQUID CHEMISTRIES CORP.™ HCY HOMOCYSTEINE REAGENT CC202 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
28 | 00817302020113 | CC053 | CC053 | HCY (Homocysteine) Level 3 control 6 x 5 mL | CAROLINA LIQUID CHEMISTRIES CORP.® HCY LEVEL 3 CONTROL KIT PART# CC053 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
29 | 00817302020106 | CC052 | CC052 | HCY (Homocysteine) Level 2 control 6 x 5 mL | CAROLINA LIQUID CHEMISTRIES CORP.® HCY LEVEL 2 CONTROL KIT PART# CC052 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
30 | 00817302020090 | CC051 | CC051 | HCY (Homocysteine) Level 1 control 6 x 5 mL | CAROLINA LIQUID CHEMISTRIES CORP.® HCY LEVEL 1 CONTROL KIT PART# CC051 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
31 | 00817302020069 | CC691 | CC691 | CYST (Cystatin-C) 2 x 100 tests | CAROLINA LIQUID CHEMISTRIES CORP.® CYST CYSTATIN CC691 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
32 | 00817302020052 | BL343 | BL343 | CREAu (Creatinine, Urine) only | CAROLINA LIQUID CHEMISTRIES CORP.® UCREA RGT. KIT BL-343 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
33 | 00817302020045 | BL243 | BL243 | CREA (Creatinine) 3 x 100 tests | CAROLINA LIQUID CHEMISTRIES CORP.® CREA RGT. KIT BL-243 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
34 | 00817302020038 | ST243 | ST243 | CREA (Creatinine) 4 x 250 tests | CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 CREATININE REAGENT KIT | CAROLINA LIQUID CHEMISTRIES CORPORATION |
35 | 00817238011032 | R85321 | Fructosamine Calibrator | Fructosamine Calibrator | CLINIQA CORPORATION | |
36 | 00817238010783 | 85962 | Hemoglobin A1c Calibrators | Hemoglobin A1c Calibrators | CLINIQA CORPORATION | |
37 | 00817238010394 | 91819 | DIABETES CONTROL SAMPLE PACK | DIABETES CNTL, Smpl, 1x2x0.5mL | CLINIQA CORPORATION | |
38 | 00817238010387 | 91815 | DIABETES CONTROL BI-LEVEL | DIABETES CNTL, Bi-L | CLINIQA CORPORATION | |
39 | 00817238010035 | 91494 | CLINIQA Liquid QCTM CoV-2 IgG Control an un-assayed quality control material for CLINIQA Liquid QCTM CoV-2 IgG Control an un-assayed quality control material for SARS-CoV-2 IgG assays. | LiquidQC CoV-2 IgG Control | CLINIQA CORPORATION | |
40 | 00816784020987 | 0505-0159 | AccuPlex SARS-CoV-2 Molecular Controls Kit – Full Genome (Positive and Negative AccuPlex SARS-CoV-2 Molecular Controls Kit – Full Genome (Positive and Negative member-5 X 1.5 ml) | AccuPlex SARS-CoV-2 Molecular Controls Kit – Full Genome | LGC CLINICAL DIAGNOSTICS, INC. | |
41 | 00816784020970 | 2015-0225 | ACCURUN® Anti-SARS-CoV-2 Controls Kit Series 2000 | ACCURUN® Anti-SARS-CoV-2 Controls Kit Series 2000 | LGC CLINICAL DIAGNOSTICS, INC. | |
42 | 00816784020963 | 2015-0222 | ACCURUN® Anti-SARS-CoV-2 Controls Kit Series 1000 | ACCURUN® Anti-SARS-CoV-2 Controls Kit Series 1000 | LGC CLINICAL DIAGNOSTICS, INC. | |
43 | 00816784020918 | 0505-0133 | 0505-0133 | AccuPlex™ SARS-CoV-2 Molecular Controls kit (Positive and Negative member-5 X 1.5 ml) | AccuPlex™ SARS-CoV-2 Molecular Controls kit | LGC CLINICAL DIAGNOSTICS, INC. |
44 | 00816784020802 | 2020-0093 | 2020-0093 | ACCURUN 315 Series 500 HIV-1 RNA 5 x 1.0 mL | ACCURUN® | LGC CLINICAL DIAGNOSTICS, INC. |
45 | 00816784020710 | 2035-0007 | 2035-0007 | ACCURUN 803 NUCLEIC ACID HIV, HCV, HBV 10 x 1.2 mL | ACCURUN® | LGC CLINICAL DIAGNOSTICS, INC. |
46 | 00816784020628 | 2020-0105 | 2020-0105 | ACCURUN 345 Series 150 HIV-1 RNA, HCV RNA, HBV DNA 5 x 4.0 mL | ACCURUN® | LGC CLINICAL DIAGNOSTICS, INC. |
47 | 00816784020611 | 2020-0104 | 2020-0104 | ACCURUN 345 Series 150 HIV-1 RNA, HCV RNA, HBV DNA 5 x 1.0 mL | ACCURUN® | LGC CLINICAL DIAGNOSTICS, INC. |
48 | 00816784020604 | 2020-0098 | 2020-0098 | ACCURUN 325 Series 700 HBV DNA 5 x 4.0 mL | ACCURUN® | LGC CLINICAL DIAGNOSTICS, INC. |
49 | 00816784020598 | 2020-0096 | 2020-0096 | ACCURUN 325 Series 200 HBV DNA 5 x 4.0 mL | ACCURUN® | LGC CLINICAL DIAGNOSTICS, INC. |
50 | 00816784020581 | 2020-0095 | 2020-0095 | ACCURUN 325 Series 370 HBV DNA Positive Control 5 x 0.6 mL | ACCURUN® | LGC CLINICAL DIAGNOSTICS, INC. |