No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | M52592330 | 9233 | CFF | IMMUNOELECTROPHORETIC, IMMUNOGLOBULINS, (G, A, M) | 2 | Antiserum to Human Serum | ||
2 | M52590150 | 9015 | JZR | SUPPORT GELS | 1 | IEP Sponge Wicks (2/pkg) | ||
3 | M52558520 | 5852 | JOZ | SYSTEM, AUTOMATED PLATELET AGGREGATION | 2 | Plateletworks Combo-25 Kit | ||
4 | M5255526140 | 552614 | JHO | ELECTROPHORETIC SEPARATION, LIPOPROTEINS | 1 | SPIFE Vis Cholesterol Kit | ||
5 | M5255527030 | 552703 | CFF | Immunoelectrophoretic, Immunoglobulins, (G, A, M) | 2 | SPIFE Nexus IFE-6 Antisera Kit | ||
6 | M525AQCHP0 | AQC-HP | JPA | SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES | 2 | Actalyke QC Kit - AQC-HP | ||
7 | M52552920 | 5292 | GGP | TEST, QUALITATIVE AND QUANTITATIVE FACTOR DEFICIENCY | 2 | Protein S ELISA Kit | ||
8 | M52551280 | 5128 | GKA | ABNORMAL HEMOGLOBIN QUANTITATION | 2 | Hemolysate Reagent | ||
9 | M52590140 | 9014 | JJN | APPARATUS, ELECTROPHORESIS, FOR CLINICAL USE | 1 | Zip Zone Sponge Wicks | ||
10 | M5258JF520010 | 8JF52001 | JPA | SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES | 2 | AggRAM Module (Domestic) | ||
11 | M52563000000 | 6300000 | LXG | EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE | 1 | Pipette, Variable Volume, 10-100 microliter | ||
12 | M52557700040 | 5770004 | JBP | ACTIVATED WHOLE BLOOD CLOTTING TIME | 2 | Actalyke XL, (CSA/CE), W/ Flash Memory | ||
13 | M52556510 | 5651 | KHE | REAGENT, OCCULT BLOOD | 2 | ColoCARE Office Pack | ||
14 | M52518200 | 1820 | CFF | Immunoelectrophoretic, Immunoglobulins, (G, A, M) | 2 | V8 WASTE DRAWER PACK | ||
15 | M52592500 | 9250 | CFF | IMMUNOELECTROPHORETIC, IMMUNOGLOBULINS, (G, A, M) | 2 | Antiserum to Human IgE | ||
16 | M5255526040 | 552604 | CIN | ELECTROPHORETIC SEPARATION, ALKALINE PHOSPHATASE ISOENZYMES | 2 | SPIFE Alkaline Phosphatase Gel Kit | ||
17 | M5255525970 | 552597 | CFF | IMMUNOELECTROPHORETIC, IMMUNOGLOBULINS, (G, A, M) | 2 | Blade Applicator Kit, 12 Sample | ||
18 | M5255524710 | 552471 | CEF | ELECTROPHORETIC, PROTEIN FRACTIONATION | 1 | SPIFE SPE HI RES 20 KIT | ||
19 | M5255524570 | 552457 | CFF | IMMUNOELECTROPHORETIC, IMMUNOGLOBULINS, (G, A, M) | 2 | SPIFE IgG IEF-10 Kit | ||
20 | M5255523040 | 552304 | CEF | ELECTROPHORETIC, PROTEIN FRACTIONATION | 1 | QUICKGEL SPE Gel Kit | ||
21 | M5255522890 | 552289 | CFF | IMMUNOELECTROPHORETIC, IMMUNOGLOBULINS, (G, A, M) | 2 | SPIFE ULTRA IFE-6 ANTISERA KIT | ||
22 | M5255521640 | 552164 | CFF | IMMUNOELECTROPHORETIC, IMMUNOGLOBULINS, (G, A, M) | 2 | SPIFE Ultra ImmunoFix-9 Antisera Kit | ||
23 | M5255521360 | 552136 | CEF | ELECTROPHORETIC, PROTEIN FRACTIONATION | 1 | QUICKGEL MODIFIED APPLICATOR BLADES AND DEEP WELL CUPS | ||
24 | M5255521250 | 552125 | CFF | IMMUNOELECTROPHORETIC, IMMUNOGLOBULINS, (G, A, M) | 2 | SPIFE Ultra ImmunoFix-15 Antisera Kit | ||
25 | M5255519410 | 551941 | JHO | ELECTROPHORETIC SEPARATION, LIPOPROTEINS | 1 | SPIFE Vis Cholesterol Reagent Kit | ||
26 | M52553680 | 5368 | GHR | REAGENT, PLATELET AGGREGATION | 2 | Collagen Reagent | ||
27 | M52553600 | 5360 | GGP | TEST, QUALITATIVE AND QUANTITATIVE FACTOR DEFICIENCY | 2 | Rocket Stain | ||
28 | M52553410 | 5341 | JPD | HEMOGLOBIN A2 QUANTITATION | 2 | Beta-Thal HbA2 Quik Column Kit | ||
29 | M52553390 | 5339 | JCM | CONTROL, HEMOGLOBIN, ABNORMAL | 2 | Normal HbA2 Quik Column Control | ||
30 | M52551340 | 5134 | JJT | ENZYME CONTROLS (ASSAYED AND UNASSAYED) | 1 | CK/LD Isoenzyme Control (5 x 2 mL) | ||
31 | M52551270 | 5127 | GKA | ABNORMAL HEMOGLOBIN QUANTITATION | 2 | Hemolysate Reagent | ||
32 | M52551250 | 5125 | GKA | ABNORMAL HEMOGLOBIN QUANTITATION | 2 | Hemolysate Reagent | ||
33 | M52551020 | 5102 | CIN | ELECTROPHORETIC SEPARATION, ALKALINE PHOSPHATASE ISOENZYMES | 2 | Alkaline Phosphatase Indolyl Blue Reagent Kit | ||
34 | M52550930 | 5093 | LXG | EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE | 1 | Bufferizer | ||
35 | M52550900 | 5090 | LXG | EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE | 1 | Zip Zone Prep (1 x 60 mL) | ||
36 | M52550850 | 5085 | KHE | REAGENT, OCCULT BLOOD | 2 | ColoScreen-ES Take Home Pack | ||
37 | M52550830 | 5083 | KHE | REAGENT, OCCULT BLOOD | 2 | ColoScreen III 1000 Slide Pack | ||
38 | M52550820 | 5082 | KHE | REAGENT, OCCULT BLOOD | 2 | ColoScreen III Lab Pack | ||
39 | M52550050 | 5005 | KEM | AGENT, CLEARING | 1 | Clear Aid | ||
40 | M5255000910 | 500091 | KHE | REAGENT, OCCULT BLOOD | ColoScreen Developer | |||
41 | M52540840 | 4084 | JQW | STATION, PIPETTING AND DILUTING, FOR CLINICAL USE | 1 | Super Z Applicator (8-sample) | ||
42 | M52536150 | 3615 | GJG | Pipette, Quantitative, Hematology | 1 | H-Pette II (No Blade, Metal Canula) (1000 pieces) | ||
43 | M52536120 | 3612 | GJG | Pipette, Quantitative, Hematology | 1 | H-Pette with Blade (1000 pieces) | ||
44 | M52534270 | 3427 | LXG | EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE | 1 | SPIFE Urine/CSF Protein Accessories (50 templates plus blotters) | ||
45 | M52534260 | 3426 | JBD | SYSTEM, ANALYSIS, ELECTROPHORETIC HEMOGLOBIN | 2 | QuickGel Accessory Kit | ||
46 | M52534250 | 3425 | JJY | Multi-analyte controls, all kinds (assayed) | 1 | SPE Abnormal Control (10 x 2 mL) | ||
47 | M52530580 | 3058 | CIN | ELECTROPHORETIC SEPARATION, ALKALINE PHOSPHATASE ISOENZYMES | 2 | TITAN GEL Alkaline Phosphatase Kit | ||
48 | M52530410 | 3041 | CEF | ELECTROPHORETIC, PROTEIN FRACTIONATION | 1 | TITAN GEL Serum Protein Kit | ||
49 | M52530240 | 3024 | CEF | ELECTROPHORETIC, PROTEIN FRACTIONATION | 1 | Titan III Cellulose Acetate (94 x 76 mm) | ||
50 | M52523190 | 2319 | LXG | EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE | 1 | SPIFE 4000 Applicator Blades |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00695684710033 | 71003 | Tri-level, For use with qualitative hCG serum tests. | HCG SERUM CONTROLS | GERMAINE LABORATORIES, INC | |
2 | 00695684710026 | 71002 | Bi-level, For use with qualitative hCG urine tests. | HCG URINE CONTROLS | GERMAINE LABORATORIES, INC | |
3 | 00657498002377 | 3063-006 | 3063-006 | A single level reference control intended for use on Hemo Control Hemoglobin Mea A single level reference control intended for use on Hemo Control Hemoglobin Measuring system. | HGB Controls - High | STANBIO LABORATORY, L.P. |
4 | 00657498002360 | 3063-003 | 3063-003 | A single level reference control intended for use on Hemo Control Hemoglobin Mea A single level reference control intended for use on Hemo Control Hemoglobin Measuring system. | HGB Controls - High | STANBIO LABORATORY, L.P. |
5 | 00657498002353 | 3062-006 | 3062-006 | A single level reference control intended for use on Hemo Control Hemoglobin Mea A single level reference control intended for use on Hemo Control Hemoglobin Measuring system. | HGB Controls - Normal | STANBIO LABORATORY, L.P. |
6 | 00657498002346 | 3062-003 | 3062-003 | A single level reference control intended for use on Hemo Control Hemoglobin Mea A single level reference control intended for use on Hemo Control Hemoglobin Measuring system. | HGB Controls - Normal | STANBIO LABORATORY, L.P. |
7 | 00657498002339 | 3061-006 | 3061-006 | A single level reference control intended for use on Hemo Control Hemoglobin Mea A single level reference control intended for use on Hemo Control Hemoglobin Measuring system. | HGB Controls - Low | STANBIO LABORATORY, L.P. |
8 | 00657498002322 | 3061-003 | 3061-003 | A single level reference control intended for use on Hemo Control Hemoglobin Mea A single level reference control intended for use on Hemo Control Hemoglobin Measuring system. | HGB Controls - Low | STANBIO LABORATORY, L.P. |
9 | 00657498002032 | 3060-101H | 3060-101H | A single level reference control intended for use on HemoPoint® H2 Hemoglobin te A single level reference control intended for use on HemoPoint® H2 Hemoglobin testing system. | Hgb Control, High | STANBIO LABORATORY, L.P. |
10 | 00657498002025 | 3060-101N | 3060-101N | A single level reference control intended for use on HemoPoint® H2 Hemoglobin te A single level reference control intended for use on HemoPoint® H2 Hemoglobin testing system. | Hgb Control, Normal | STANBIO LABORATORY, L.P. |
11 | 00657498002018 | 3060-101L | 3060-101L | A single level reference control intended for use on HemoPoint® H2 Hemoglobin te A single level reference control intended for use on HemoPoint® H2 Hemoglobin testing system. | Hgb Control, Low | STANBIO LABORATORY, L.P. |
12 | 00657498001431 | 3065-201 | 3065-201 | A bi-level reference control set intended for use on HemoPoint® H2 Hemoglobin t A bi-level reference control set intended for use on HemoPoint® H2 Hemoglobin testing system. | Bi-Level Hgb Controls | STANBIO LABORATORY, L.P. |
13 | 00657498001219 | G428-86 | G428-86 | Use as a control serum to monitor the accuracy and precision of manual and autom Use as a control serum to monitor the accuracy and precision of manual and automated methods used in clinical chemistry. | Ser-T-Fy 2, Level 2 Control | STANBIO LABORATORY, L.P. |
14 | 00657498001202 | G427-86 | G427-86 | Use as a control serum to monitor the accuracy and precision of manual and autom Use as a control serum to monitor the accuracy and precision of manual and automated methods used in clinical chemistry. | Ser-T-Fy 1, Level 1 Control | STANBIO LABORATORY, L.P. |
15 | 00657498001189 | 1235-305 | 1235-305 | For Use as hCG Pregnancy Controls in Qualitative Serum hCG Pregnancy Procedures. | hCG Tri-Level Serum Controls | STANBIO LABORATORY, L.P. |
16 | 00657498001172 | 1225-205 | 1225-205 | For Use as hCG Pregnancy Controls in Qualitative Urine hCG Pregnancy Procedures. | hCG Bi-Level Urine Controls | STANBIO LABORATORY, L.P. |
17 | 00657498000243 | 3065-601 | 3065-601 | A bi-level reference control set intended for use on HemoPoint® H2 Hemoglobin t A bi-level reference control set intended for use on HemoPoint® H2 Hemoglobin testing system. | Bi-Level Hgb Controls | STANBIO LABORATORY, L.P. |
18 | 00630414284996 | 10873685 | OQDC17 | Assayed control for RF, ASL and CRP assays on BN Systems | N/T Rheumatology Control SL/2 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
19 | 00630414284989 | 10873684 | OQDB17 | Assayed control for RF, ASL and CRP assays on BN Systems | N/T Rheumatology Control SL/1 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
20 | 00630414237503 | 10873663 | OPJF05 | Assayed accuracy and precision controls in the determination of free light chain Assayed accuracy and precision controls in the determination of free light chains (FLC) type kappa and type lambda on BN Systems. | N FLC CONTROL SL2 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
21 | 00630414237480 | 10873661 | OPJE05 | Assayed accuracy and precision controls in the determination of free light chain Assayed accuracy and precision controls in the determination of free light chains (FLC) type kappa and type lambda on BN Systems. | N FLC CONTROL SL1 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
22 | 00630414202174 | 10309926 | 108868 | For in vitro diagnostic use for quality control of pH/Blood Gas Analyzers, ISE A For in vitro diagnostic use for quality control of pH/Blood Gas Analyzers, ISE Analyzers, CO-oximeters and Metabolite Analyzers. | RAPIDQC® Complete Level 2 | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
23 | 00630414202167 | 10309927 | 108869 | For in vitro diagnostic use for quality control of pH/Blood Gas Analyzers, ISE A For in vitro diagnostic use for quality control of pH/Blood Gas Analyzers, ISE Analyzers, CO-oximeters and Metabolite Analyzers. | RAPIDQC® Complete Level 3 | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
24 | 00630414202150 | 10309925 | 108860 | For in vitro diagnostic use for quality control of pH/Blood Gas Analyzers, ISE A For in vitro diagnostic use for quality control of pH/Blood Gas Analyzers, ISE Analyzers, CO-oximeters and Metabolite Analyzers. | RAPIDQC® Complete Level 1 | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
25 | 00630414195131 | 10316535 | 116189 | Calibration Verification Material (CVM®) to verify the calibration of blood gas, Calibration Verification Material (CVM®) to verify the calibration of blood gas, electrolytes, total hemoglobin (tHb) and metabolite systems. | CVM® Calibration Verification Material | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
26 | 00630414121802 | 10330034 | 570407 | Calibration Verification Material for Hematocrit (CVM® Hct) is a unique material Calibration Verification Material for Hematocrit (CVM® Hct) is a unique material formulated to verify the calibration of conductivity-based hematocrit test systems. | CVM® Hct Calibration Verification Material for Hematocrit Systems | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
27 | 00630414121628 | 10311387 | 570097 | For in vitro diagnostic use for verifying glucose and lactate sensor performance For in vitro diagnostic use for verifying glucose and lactate sensor performance on the RAPIDLab® 1260 & 1265 systems | RAPIDLab® High G/L | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
28 | 00630414112985 | 10340375 | 477440000 | The blood gas Proficiency Pre-Test is a pre-proficiency test material supplied t The blood gas Proficiency Pre-Test is a pre-proficiency test material supplied three times a year for verifying performance of pH/blood gas, electrolyte, metabolite and CO-oximetry analyzers. | Proficiency Pre-Test | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
29 | 00628063401222 | SM-057 | DC-TROL LEVELS 1 & 2 | SEKISUI DIAGNOSTICS, LLC | ||
30 | 00628063400461 | SM-056 | SM-056 | DC-TROL Level 2 | SEKISUI DIAGNOSTICS, LLC | |
31 | 00628063400454 | SM-052 | SM-052 | DC-TROL Level 1 | SEKISUI DIAGNOSTICS, LLC | |
32 | 00386100004385 | 10340 | 10340 | EasyRA Analyzer - ISE & LIS | EasyRA Analyzer (ISE&LIS) | MEDICA CORPORATION |
33 | 00386100004378 | 10360 | 10360 | EasyRA Analyzer - LIS | EasyRA Analyzer (LIS) | MEDICA CORPORATION |
34 | 00386100002282 | 5423-0041 | 5423-0041 | ISE Reagent Pack for use with EasyRA Analyzers | ISE Reagent Pack | MEDICA CORPORATION |
35 | 00386100002206 | 10224-4 | 10224-4 | LDL Cholesterol Reagent Kit for use with EasyRA Analyzers | LDL CHOL Reagent Kit | MEDICA CORPORATION |
36 | 00386100001889 | 10794 | 10794 | EasyQC Quality Control Kit - Level B for use with EasyRA Analyzer | QC Kit, Level B | MEDICA CORPORATION |
37 | 00386100001872 | 10793 | 10793 | EasyQC Quality Control Kit - Level for use with EasyRA Analyzer | QC Kit, Level A | MEDICA CORPORATION |
38 | 00385480561983 | PHOX | 56198 | Linearity Standard Set G Multipack | STAT PROFILE | NOVA BIOMEDICAL CORPORATION |
39 | 00385480534567 | PRIME ABG | 53456 | Prime Auto QC Cartridge ABG 100 Sample | STAT PROFILE | NOVA BIOMEDICAL CORPORATION |
40 | 00385480534550 | PRIME CCS | 53455 | Prime Auto QC Cartridge CCS 100 Sample | STAT PROFILE | NOVA BIOMEDICAL CORPORATION |
41 | 00385480531085 | PRIME ABG | 53108 | Prime Auto QC Cartridge ABG 300 Sample | STAT PROFILE | NOVA BIOMEDICAL CORPORATION |
42 | 00385480531078 | PRIME ABG | 53107 | Prime Auto QC Cartridge ABG 200 Sample | STAT PROFILE | NOVA BIOMEDICAL CORPORATION |
43 | 00385480528641 | PRIME CCS | 52864 | Prime Auto QC Cartridge CCS 300 Sample | STAT PROFILE | NOVA BIOMEDICAL CORPORATION |
44 | 00385480527149 | Prime ABG/CCS | 52714 | Stat Profile Prime Ampuled Control ABG/CCS | Stat Profile | NOVA BIOMEDICAL CORPORATION |
45 | 00385480496407 | Plus | 49640 | Nova Max Plus Glu/Ket Control Solution - Mid | NOVA MAX | NOVA BIOMEDICAL CORPORATION |
46 | 00385480491877 | phox ultra/ccx | 49187 | Stat Profile pHOx Ultra/CCX Control CO-Ox Tri Level L7, 8 ,9 (amps) | STAT PROFILE | NOVA BIOMEDICAL CORPORATION |
47 | 00385480491846 | phox ultra/ccx | 49184 | Stat Profile pHOx Ultra/CCX Control Chemistry L4, 5 (amps) | STAT PROFILE | NOVA BIOMEDICAL CORPORATION |
48 | 00385480489355 | phox ultra/ccx | 48935 | Stat Profile pHOx Ultra/CCX Blood Gas Controls Multipack L1, 2, 3 (Amps) | STAT PROFILE | NOVA BIOMEDICAL CORPORATION |
49 | 00385480489287 | PHOX ULTRA/CCX | 48928 | Stat Profile pHOx Ultra/CCX Chemistry Controls Auto-Cartridge with Creat 6/Day | STAT PROFILE | NOVA BIOMEDICAL CORPORATION |
50 | 00385480489270 | PHOX ULTRA/CCX | 48927 | Stat Profile pHOx Ultra/CCX Chemistry Controls Auto-Cartridge with Creat 4/Day | STAT PROFILE | NOVA BIOMEDICAL CORPORATION |