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 | 03610522142415 | 12011331 | 12011331 | Liquichek Diabetes Control Level Trilevel MiniPak (A human whole blood assayed Liquichek Diabetes Control Level Trilevel MiniPak (A human whole blood assayed diabetes control.) | Liquichek | BIO-RAD LABORATORIES, INC. |
2 | 03610522141708 | 12011310 | 12011310 | Liquichek Diabetes Control Level 3 (A human whole blood assayed diabetes control.) | Liquichek | BIO-RAD LABORATORIES, INC. |
3 | 03610522141692 | 12011309 | 12011309 | Liquichek Diabetes Control Level 2 (A human whole blood assayed diabetes control.) | Liquichek | BIO-RAD LABORATORIES, INC. |
4 | 03610522141685 | 12011308 | 12011308 | Liquichek Diabetes Control Level 1 (A human whole blood assayed diabetes control.) | Liquichek | BIO-RAD LABORATORIES, INC. |
5 | 03610521185963 | 12006555 | 12006555 | BioPlex 2200 25-OH Vitamin D Control Lot Data | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
6 | 03610521185956 | 12006554 | 12006554 | BioPlex 2200 25-OH Vitamin D Control Set | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
7 | 03610521176510 | 12006327 | 12006327 | Liquichek AMH Control Trilevel (A human serum assayed AMH control.) | Liquichek | BIO-RAD LABORATORIES, INC. |
8 | 03610520992753 | 12000678 | 12000678 | BioPlex 2200 ToRC IgM Control Set | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
9 | 03610520653005 | 12000654 | 12000654 | BioPlex 2200 Syphilis Total & RPR Control Lot Data | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
10 | 03610520652794 | 12000653 | 12000653 | BioPlex 2200 Syphilis Total & RPR Control Set | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
11 | 03610520506431 | 12000880 | 12000880 | BioPlex 2200 Lyme Total Control CD | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
12 | 03610520506424 | 12000879 | 12000879 | BioPlex 2200 Lyme Total Control Set | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
13 | 03610520269541 | 12000673 | 12000673 | BioPlex 2200 ToRC IgM Control Lot Data | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
14 | 03610520267233 | 12004312 | 12004312 | InteliQ Homocysteine Control MiniPak (A human serum assayed homocysteine control.) | InteliQ | BIO-RAD LABORATORIES, INC. |
15 | 03610520267226 | 12004311 | 12004311 | InteliQ Homocysteine Control Level 3 (A human serum assayed homocysteine control.) | InteliQ | BIO-RAD LABORATORIES, INC. |
16 | 03610520267219 | 12004310 | 12004310 | InteliQ Homocysteine Control Level 2 (A human serum assayed homocysteine control.) | InteliQ | BIO-RAD LABORATORIES, INC. |
17 | 03610520242582 | 12004309 | 12004309 | InteliQ Homocysteine Control Level 1 (A human serum assayed homocysteine control.) | InteliQ | BIO-RAD LABORATORIES, INC. |
18 | 03610230007945 | 1300023953 | Yumizen C1200 L2 Cystatin C Control | HORIBA ABX SAS | ||
19 | 03610230007938 | 1300023951 | Yumizen C1200 L1 Cystatin C Control | HORIBA ABX SAS | ||
20 | 03610230007921 | 1300023950 | Yumizen C1200 C02 Control | HORIBA ABX SAS | ||
21 | 03610230005118 | 1220001650 | ABX PENTRA CO2 CONTROL | HORIBA ABX SAS | ||
22 | 03607360025154 | 2515 | 2515 | Device intended for measurement of HbA1c in whole blood using capillary electrophoresis | CAPI 3 Hb A1c | SEBIA |
23 | 03607360022153 | 2215 | 2215 | Measure HbA1c from whole blood using a Capillary instrument | MINICAP Hb A1c | SEBIA |
24 | 03607360020159 | 2015 | 2015 | Device for the detection and quantitation of HbA1c in whole blood using capillar Device for the detection and quantitation of HbA1c in whole blood using capillary electrophoresis | CAPILLARYS Hb A1c | SEBIA |
25 | 00896863002257 | 1313-31 | 1313-31 | The Ammonia/Alcohol Control is intended as a means of monitoring various ammonia The Ammonia/Alcohol Control is intended as a means of monitoring various ammonia and ethanol assay methods to validate quantitation of patient samples. It is supplied in three level, 3x5mL, as a ready-to-use liquid requiring no reconstitution or dilution. It is fortified with ethanol and reagent grade chemicals. Preservatives have been added to inhibit microbial growth. | Ammonia Alcohol Control Level 3 Set 3x5mL | QUANTIMETRIX CORPORATION |
26 | 00896863002240 | 1312-31 | 1312-31 | The Ammonia/Alcohol Control is intended as a means of monitoring various ammonia The Ammonia/Alcohol Control is intended as a means of monitoring various ammonia and ethanol assay methods to validate quantitation of patient samples. It is supplied in three level, 3x5mL, as a ready-to-use liquid requiring no reconstitution or dilution. It is fortified with ethanol and reagent grade chemicals. Preservatives have been added to inhibit microbial growth. | Ammonia Alcohol Control Level 2 Set 3x5mL | QUANTIMETRIX CORPORATION |
27 | 00896863002233 | 1311-31 | 1311-31 | The Ammonia/Alcohol Control is intended as a means of monitoring various ammonia The Ammonia/Alcohol Control is intended as a means of monitoring various ammonia and ethanol assay methods to validate quantitation of patient samples. It is supplied in three level, 3x5mL, as a ready-to-use liquid requiring no reconstitution or dilution. It is fortified with ethanol and reagent grade chemicals. Preservatives have been added to inhibit microbial growth. | Ammonia Alcohol Control Level 1 Set 3x5mL | QUANTIMETRIX CORPORATION |
28 | 00896863002073 | 1450-01 | 1450-01 | The Dropper Spinal Fluid Control is intended as a means of monitoring spinal flu The Dropper Spinal Fluid Control is intended as a means of monitoring spinal fluid analyte methods to validate quantitation of patient samples. It is supplied in two levels in ready-to-use liquid, requiring no reconstitution. It is prepared in a human protein matrix fortified to target levels with purified chemicals. Preservatives have been added to inhibit microbial growth. | Dropper Spinal Fluid Control Level 1&2 Set 2x3mL | QUANTIMETRIX CORPORATION |
29 | 00896863002066 | 1510-02 | 1510-02 | The Dropper A1c Diabetes Control is intended for the quality control of analytic The Dropper A1c Diabetes Control is intended for the quality control of analytical procedures used to quantitate HbA1c. It is supplied in two levels as a frozen, ready-to-use material that requires no reconstitution. It consists of human whole blood modified to target levels with reagent chemicals to produce the desired reaction when tested by the methods indicated in the product insert. Stabilizers and preservatives have been added to maintain shelf life and inhibit microbial growth. | Dropper A1c Diabetes Control Level 1&2 Set 4x0.9mL | QUANTIMETRIX CORPORATION |
30 | 00896863002059 | 1290-01 | 1290-01 | The Complete D 25-OH Vitamin D control is intended to monitor the performance of The Complete D 25-OH Vitamin D control is intended to monitor the performance of clinical assays used to quantitate total 25-OH Vitamin D. It is supplied in two levels, 3mL per vial. Each kit contains 2 vials of level 1 and 2 vials of level 2 controls. The controls are liquid, ready to use and require no reconstitution of dilution. The controls are prepared in a human serum matrix fortified with analytes and preservatives. This control contains both 25-OH Vitamin D2 and D3, and when combined represent clinically relevant levels of Total Vitamin D. | Complete D 25-OH Vitamin Control Level 1&2 Set 4x3mL | QUANTIMETRIX CORPORATION |
31 | 00896863002011 | 1452-31 | 1452-31 | The Dropper Spinal Fluid Control is intended as a means of monitoring spinal flu The Dropper Spinal Fluid Control is intended as a means of monitoring spinal fluid analyte methods to validate quantitation of patient samples. It is supplied in two levels in ready-to-use liquid, requiring no reconstitution. It is prepared in a human protein matrix fortified to target levels with purified chemicals. Preservatives have been added to inhibit microbial growth. | Dropper Spinal Fluid Control Level 2 Set 3x3mL | QUANTIMETRIX CORPORATION |
32 | 00896863002004 | 1451-31 | 1451-31 | The Dropper Spinal Fluid Control is intended as a means of monitoring spinal flu The Dropper Spinal Fluid Control is intended as a means of monitoring spinal fluid analyte methods to validate quantitation of patient samples. It is supplied in two levels in ready-to-use liquid, requiring no reconstitution. It is prepared in a human protein matrix fortified to target levels with purified chemicals. Preservatives have been added to inhibit microbial growth. | Dropper Spinal Fluid Control Level 1 Set 3x3mL | QUANTIMETRIX CORPORATION |
33 | 00894046001608 | 005 | 005 | Advocate BMB Control Solutions High | Advocate BMB Control Solutions High | DIABETIC SUPPLY OF SUNCOAST, INC. |
34 | 00894046001585 | 003 | BMB003 | Advocate Control Solutions Level 1 Low 4 ml Bottle | Advocate Control Solutions Low | DIABETIC SUPPLY OF SUNCOAST, INC. |
35 | 00894030002871 | APX03AB0318 | Embrace TALK Control Solution L1 (LO) | OMNIS HEALTH, LLC | ||
36 | 00894030002864 | APX03AB0317 | Embrace TALK control solution L2 | Embrace TALK control solution HI | OMNIS HEALTH, LLC | |
37 | 00894030002826 | APX03AB0313HW | HealthWise Embrace TALK Blood Glucose Monitoring System (Starter Kit) | OMNIS HEALTH, LLC | ||
38 | 00894030002703 | APX02AB0510 | Embrace Control Solution Low | OMNIS HEALTH | ||
39 | 00894030002697 | APX02AB0511 | Embrace Control Solution Hi | OMNIS HEALTH | ||
40 | 00894030002680 | APX02AB0502 | Embrace 50ct Test Strip | OMNIS HEALTH | ||
41 | 00894030002666 | APX01AB0500VK | Embrace Value Kit (50ct Included) | OMNIS HEALTH | ||
42 | 00894030002611 | APX01AB0200N | Embrace Blood Glucose Monitor | OMNIS HEALTH, LLC | ||
43 | 00894030002581 | APX02GS0202RF | Embrace Gestational Diabetes Package - RETAIL (5 vials) | OMNIS HEALTH | ||
44 | 00894030002574 | APX02GS0202RF | Embrace Gestational Diabetes - Strips Refill Bundle (4 vials) | OMNIS HEALTH | ||
45 | 00894030002567 | APX01GS0200-L | Embrace Gestational Diabetes Package - LARGE (9 vials) | OMNIS HEALTH | ||
46 | 00894030002550 | APX01GS0200-S | Embrace Gestational Diabetes Package - SMALL (5 vials) | OMNIS HEALTH | ||
47 | 00894030002543 | APX01AGS0100-SR | EmbraceEVO Gestational Diabetes Package - RETAIL (5 vials) | OMNIS HEALTH | ||
48 | 00894030002536 | APX01AK0200VK | Embrace Meter Value Pack (incl. 50ct) | OMNIS HEALTH | ||
49 | 00894030002482 | APX01GS0100-L | EmbraceEVO Gestational Diabetes Package - LARGE (9 vials) | OMNIS HEALTH | ||
50 | 00894030002475 | APX01GS0100-S | EmbraceEVO Gestational Diabetes Package - SMALL (5 vials) | OMNIS HEALTH |