No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00357599000356 | 71750 | 71750 | FreeStyle Precision Neo Blood Glucose Test Strips | NBW | SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | FreeStyle Precision Neo | |
2 | 00357599000349 | 71749 | 71749 | FreeStyle Precision Neo Blood Glucose Test Strips | NBW | SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | FreeStyle Precision Neo | |
3 | 00357599000332 | 71748 | 71748 | FreeStyle Precision Neo Blood Glucose Test Strips Not For Retail Sale | NBW | SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | FreeStyle Precision Neo | |
4 | 00357599000301 | 71741 | 71741 | FreeStyle Precision Neo Blood Glucose Monitoring System Not For Retail Sale | NBW,LFR | SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER,Glucose dehydrogenase, glucose | FreeStyle Precision Neo | |
5 | 00093815751755 | 75175 | 75175 | FreeStyle Precision Neo Blood Glucose Monitoring System | NBW,LFR | SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER,Glucose dehydrogenase, glucose | FreeStyle Precision Neo | |
6 | 00093815751700 | 75170 | 75170 | FreeStyle Libre Pro Software | PHV | Continuous glucose monitor retrospective data analysis software | 1 | FreeStyle Libre Pro |
7 | 00093815715818 | 71581 | 71581 | FreeStyle Precision Neo Blood Glucose Test Strips | NBW,LFR | SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER,Glucose dehydrogenase, glucose | FreeStyle Precision Neo | |
8 | 00093815715795 | 71579 | 71579 | FreeStyle Precision Neo Blood Glucose Test Strips | NBW,LFR | SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER,Glucose dehydrogenase, glucose | FreeStyle Precision Neo | |
9 | 00357599000417 | 71760 | 71760 | FreeStyle Libre Pro Reader Kit US DOD | MDS | Sensor, glucose, invasive | FreeStyle Libre Pro | |
10 | 00357599824006 | 72154-01 | 72154-01 | LibreLinkUp | PJT | Continuous glucose monitor secondary display | 2 | LibreLinkUp |
11 | 00357599716875 | 71687 | 71687 | FreeStyle Libre Pro Reader Kit | MDS | Sensor, glucose, invasive | FreeStyle Libre Pro | |
12 | 00357599715625 | 71562 | 71562 | FreeStyle Libre Pro Sensor Kit | MDS | Sensor, glucose, invasive | FreeStyle Libre Pro | |
13 | 00357599715618 | 71561 | 71561 | FreeStyle Libre Pro Sensor Kit | MDS | Sensor, glucose, invasive | FreeStyle Libre Pro | |
14 | 00357599715557 | 71555 | 71555 | FreeStyle Libre Pro Reader Kit | MDS | Sensor, glucose, invasive | FreeStyle Libre Pro | |
15 | 00093815715771 | 71577 | 71577 | FreeStyle Precision Neo Blood Glucose Test Strips | NBW,LFR | SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER,Glucose dehydrogenase, glucose | FreeStyle Precision Neo | |
16 | 00699073000842 | 70851 | 70851 | Abbott Diabetes Care USB Data Cable Software | OUG | Medical device data system | Abbott | |
17 | 00357599000691 | 70901 | 70901 | Abbott SF Single Use Lancing Device | FMK | Lancet, blood | Abbott | |
18 | 00093815000839 | 70845 | 70845 | Abbott Diabetes Care USB Data Cable Software | OUG | Medical device data system | Abbott | |
19 | 00357599819002 | 72080 | 72080 | FreeStyle Libre 3 Sensor Kit NFRS | QLG | Integrated continuous glucose monitoring system, factory calibrated, not for use Integrated continuous glucose monitoring system, factory calibrated, not for use with automated insulin delivery systems | FreeStyle Libre 3 | |
20 | 00357599818005 | 72081 | 72081 | FreeStyle Libre 3 Sensor Kit US | QLG | Integrated continuous glucose monitoring system, factory calibrated, not for use Integrated continuous glucose monitoring system, factory calibrated, not for use with automated insulin delivery systems | FreeStyle Libre 3 | |
21 | 00699073709011 | 70901 | 70901 | Abbott SF Single Use Lancing Device | FMK | Lancet, blood | 2 | Abbott |
22 | 00699073708519 | 70851 | 70851 | Abbott Diabetes Care USB Data Cable Software | OUG | Medical device data system | 1 | Abbott |
23 | 00357599826000 | 72157-01 | 72157-01 | LibreViewGov | PHV | Continuous glucose monitor retrospective data analysis software | 1 | LibreView Government |
24 | 00093815710653 | 71065 | 71065 | Optium EZ Blood Glucose Monitoring System | NBW,LFR,JJX | SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER,Glucose dehydrogenase, glucose,SIN SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER,Glucose dehydrogenase, glucose,SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED) | OptiumEZ | |
25 | 00093815710424 | 71042 | 71042 | Optium EZ Blood Glucose Test Strips | LFR,NBW,JJX | Glucose dehydrogenase, glucose,SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER,SIN Glucose dehydrogenase, glucose,SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER,SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED) | OptiumEZ | |
26 | 00093815710417 | 71041 | 71041 | Optium EZ Blood Glucose Test Strips | NBW,JJX,LFR | SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER,SINGLE (SPECIFIED) ANALYTE CONTROL SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER,SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED),Glucose dehydrogenase, glucose | OptiumEZ | |
27 | 00093815708452 | 70845 | 70845 | Abbott Diabetes Care USB Data Cable Software | OUG | Medical device data system | 1 | Abbott |
28 | 00699073715012 | 71501 | 71501 | FreeStyle Lite Blood Glucose Monitoring System | LFR,NBW | Glucose dehydrogenase, glucose,SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | FreeStyle Lite | |
29 | 00699073708199 | 70819 | 70819 | FreeStyle Lite Blood Glucose Test Strips | LFR,NBW | Glucose dehydrogenase, glucose,SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | FreeStyle Lite | |
30 | 00699073708175 | 70817 | 70817 | FreeStyle Lite Blood Glucose Test Strips | LFR,NBW | Glucose dehydrogenase, glucose,SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | FreeStyle Lite | |
31 | 00699073708052 | 70805 | 70805 | FreeStyle Lite Blood Glucose Monitoring System | LFR,NBW | Glucose dehydrogenase, glucose,SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | FreeStyle Lite | |
32 | 00699073708045 | 70804 | 70804 | FreeStyle Lite Blood Glucose Monitoring System | NBW,LFR | SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER,Glucose dehydrogenase, glucose | FreeStyle Lite | |
33 | 00357599000479 | 71527 | 71527 | FreeSyle Libre Software CD | PHV | Continuous glucose monitor retrospective data analysis software | 1 | FreeStyle Libre |
34 | 00357599000240 | 71739 | 71739 | FreeStyle Libre Reader Kit US DOD | PZE | Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated | FreeStyle Libre | |
35 | 00357599000202 | 71702 | 71702 | FreeStyle Libre Sensor Kit | PZE | Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated | FreeStyle Libre | |
36 | 00357599000196 | 71536 | 71536 | FreeStyle Libre Sensor Kit | PZE | Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated | FreeStyle Libre | |
37 | 00093815803126 | 80312 | 80312 | MediSense Glucose & Ketone Control Solutions | JJX | Single (specified) analyte controls (assayed and unassayed) | MediSense | |
38 | 00093815801399 | 80139 | 80139 | MediSense Glucose & Ketone Control Solutions | JJX | Single (specified) analyte controls (assayed and unassayed) | MediSense | |
39 | 00357599000226 | 71701 | 71701 | FreeStyle Libre Reader Kit US | PZE | Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated | FreeStyle Libre | |
40 | 00357599000219 | 71525 | 71525 | FreeStyle Libre Reader Kit US | PZE | Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated | FreeStyle Libre | |
41 | 00357599000851 | 71942 | 71942 | FS Libre Sensor Kit | PZE | Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated | FreeStyle Libre | |
42 | 00699073710260 | 71026 | 71026 | FreeStyle Lite Blood Glucose Test Strips | NBW,LFR | SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER,Glucose dehydrogenase, glucose | FreeStyle Lite | |
43 | 00699073708274 | 70827 | 70827 | FreeStyle Lite Blood Glucose Test Strips | LFR,NBW | Glucose dehydrogenase, glucose,SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | FreeStyle Lite | |
44 | 00699073708229 | 70822 | 70822 | FreeStyle Lite Blood Glucose Test Strips | NBW,LFR | SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER,Glucose dehydrogenase, glucose | FreeStyle Lite | |
45 | 00699073000019 | 70804 | 70804 | FreeStyle Lite Blood Glucose Monitoring System | NBW,LFR | SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER,Glucose dehydrogenase, glucose | 2 | FreeStyle Lite |
46 | 00357599001025 | 71939 | 71939 | FreeStyle Libre 14 day Sensor Kit NFRS | PZE | Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated | FreeStyle Libre 14 day | |
47 | 00357599002008 | 71938 | 71938 | FreeStyle Libre 14 day Reader Kit US | PZE | Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated | FreeStyle Libre 14 day | |
48 | 00357599001018 | 71940 | 71940 | FreeStyle Libre 14 day Sensor Kit | PZE | Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated | FreeStyle Libre 14 day | |
49 | 00357599000981 | 71936 | 71936 | FreeStyle Libre 14 day Reader Kit US DOD | PZE | Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated | FreeStyle Libre 14 day | |
50 | 00357599000974 | 71937 | 71937 | FreeStyle Libre 14 day Reader Kit US | PZE | Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated | FreeStyle Libre 14 day |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00885325001495 | 276265 | KetoSens BT B-Ketone Monitoring System with Test Strips (individually foiled packs x 10) | KetoSens | I-SENS, INC. | |
2 | 00885325001280 | 276156 | KetoSens B-Ketone 10T Test Strips with 10T lancets | KetoSens | I-SENS, INC. | |
3 | 00885325001273 | 276155 | KetoSens B-Ketone Test Strip (individually foiled packs x 30) with 30T lancets | KetoSens | I-SENS, INC. | |
4 | 00885325001198 | 276150 | KetoSens B-Ketone Test Strip (individual foiled packs x 30) | KetoSens | I-SENS, INC. | |
5 | 00885325001075 | 276262 | KetoSens B-Ketone Monitoring System with Test Strips (individually foiled packs x 10) | KetoSens | I-SENS, INC. | |
6 | 00885325001068 | 276154 | KetoSens B-Ketone Test Strips (individually foiled packs x 50) with 50T lancets | KetoSens | I-SENS, INC. | |
7 | 00885325000870 | 276153-206 | KetoSens B-Ketone Test Strip (individual foiled packs x 10) | KetoSens | I-SENS, INC. | |
8 | 00885325000863 | 276151 | KetoSens B-Ketone Test Strip (individual foiled packs x 50) | KetoSens | I-SENS, INC. | |
9 | 00885325000856 | 276261-201 | KetoSens B-Ketone Monitoring System with Lancets | KetoSens | I-SENS, INC. | |
10 | 00866457000372 | MD6 | Ketone Test Strips | Bruno | BRUNO PHARMA INNOVATIONS, LLC | |
11 | 00860060002341 | S11007 | KETOCOACH METER ONLY | AMVENTUREX, INC. | ||
12 | 00860060002334 | S5800335 | KETOCOACH CONTROL SOLUTION Level 2 | AMVENTUREX, INC. | ||
13 | 00860060002327 | S5640791 | KETOCOACH 50 BLOOD KETONE TEST STRIPS | AMVENTUREX, INC. | ||
14 | 00860060002310 | s11006 | KETOCOACH BLOOD KETONE METER | AMVENTUREX, INC. | ||
15 | 00860005745913 | TD-4279 | bkt ß-Ketone Test Strips (50 pcs/box) | ADAM LAWRENCE | ||
16 | 00855944007239 | EZR-101 | EZR-101-100 | Easy@Home KetoneTest Strips; Reagent Strips for Urinalysis; Ideal for Keto Diet; 100 ct | Easy@Home KetoneTest Strips (100 test kit) | EASY HEALTHCARE CORPORATION |
17 | 00855944007222 | EZR-101 | EZR-101-150 | Easy@Home KetoneTest Strips; Reagent Strips for Urinalysis; Ideal for Keto Diet; 150 ct | Easy@Home KetoneTest Strips (150 test kit) | EASY HEALTHCARE CORPORATION |
18 | 00851225008025 | 3100-050 | Lucidplus B-Ketone Test Strips 50 count | VIDAN DIAGNOSTICS LLC | ||
19 | 00850017460034 | S84102 | S84102 | Complete Kit | BIOCOACH Blood Glucose and Ketone Monitoring System | AMVENTUREX, INC. |
20 | 00850011007143 | TNR 10SG | TNR 10SG | Tanner Scientific 10SG, 100/BTL, CLIA WAIVED, Tests for: Glucose, Bilirubin, Ket Tanner Scientific 10SG, 100/BTL, CLIA WAIVED, Tests for: Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite, Leukocyte Esterase | Tanner Scientific® | MERCEDES MEDICAL, LLC |
21 | 00850001462334 | v1 | GOJJI BLOOD KETONE TEST STRIP | GOJJI, INC. | ||
22 | 00816042013850 | 6 Connect | Multi-Functional Monitoring System | FORA | FORA CARE INC. | |
23 | 00816042013164 | Test N'GO Advance/Advance Voice/6 Connect | Ketone Test Strips | FORA | FORA CARE INC. | |
24 | 00816042013157 | 6 Connect | Ketone Test Strips | FORA | FORA CARE INC. | |
25 | 00816042013102 | Test N'GO Advance/Advance Voice/6 Connect | Ketone Test Strips | FORA | FORA CARE INC. | |
26 | 00816042013089 | 6 Connect | Ketone Test Strips | FORA | FORA CARE INC. | |
27 | 00811727011572 | H7587-CTL | H7587-CTL | Set for use as controls in quantitative procedures for Acetaminophen, Salicylate Set for use as controls in quantitative procedures for Acetaminophen, Salicylate and b-hydroxybutyrate. 6 x 5ml | Pointe Scientific, Inc. | POINTE SCIENTIFIC, INC. |
28 | 00811727011558 | H7587-58 | H7587-58 | Reagent for the quantitative determination of b-hydroxybutyrate in serum or plas Reagent for the quantitative determination of b-hydroxybutyrate in serum or plasma. For in vitro diagnostic use only. 1 x 50ml, 1 x 8ml | Pointe Scientific, Inc. | POINTE SCIENTIFIC, INC. |
29 | 00810038632445 | EZR-101 | EZR-101-50P | Easy@Home Ketone Test Strips (50 Pack) | Easy@Home Ketone Test Strips (50 Pack) | EASY HEALTHCARE CORPORATION |
30 | 00810038631431 | EZR-101 | EZR-101-20(P) | Easy@Home Ketone Test Strips (20 Pack) | Easy@Home Ketone Test Strips (20 Pack) | EASY HEALTHCARE CORPORATION |
31 | 00722066005255 | U11.1-1S100 | Rapid Response 11 Parameter Urinalysis Reagent Strips (ASC/GLU/BLD/LEU/PRO/NIT/K Rapid Response 11 Parameter Urinalysis Reagent Strips (ASC/GLU/BLD/LEU/PRO/NIT/KET/PH/BIL/URO/SG) - 100 tests/ kit are for qualitative or semi-quantitative determination of Ascorbic Acid, Glucose, Blood, Leukocyte, Protein, Nitrite, Ketone, pH, Bilirubin, Urobilinogen, Specific Gravity in urine. | Rapid Response | BTNX INC | |
32 | 00722066004364 | U5.3-1S100 | U5.3-1S100 | Rapid Response 5 Parameter Urinalysis Reagent Strips (KET/PH/PRO/GLU/BLD) – 100 Rapid Response 5 Parameter Urinalysis Reagent Strips (KET/PH/PRO/GLU/BLD) – 100 tests/ kit are for qualitative or semi-quantitative determination of Ketone, pH, Protein, Glucose and Blood in urine. | Rapid Response | BTNX INC |
33 | 00722066003022 | U10.1-1S25 | U10.1-1S25 | Rapid Response 10 Parameter Urinalysis Reagent Strips (GLU/BIL/KET/SG/BLO/PH/PRO Rapid Response 10 Parameter Urinalysis Reagent Strips (GLU/BIL/KET/SG/BLO/PH/PRO/URO/NIT/LEU) - 25 tests/ kit are for qualitative or semi-quantitative detection of Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite, Leukocytes in urine. | Rapid Response | BTNX INC |
34 | 00722066001936 | U120 | Urine Analyzer 120 | Rapid Response | BTNX INC | |
35 | 00722066001219 | UA-500 | Urine Analyzer 500 | Rapid Response | BTNX INC | |
36 | 00722066001172 | U10.1-1S100 | U10.1-1S100 | Rapid Response 10 Parameter Urinalysis Reagent Strips (GLU/BLD/LEU/PRO/NIT/KET/P Rapid Response 10 Parameter Urinalysis Reagent Strips (GLU/BLD/LEU/PRO/NIT/KET/PH/BIL/URO/SG) - 100 tests/ kit are for qualitative or semi-quantitative determination of Glucose, Blood, Leukocyte, Protein, Nitrite, Ketone, pH, Bilirubin, Urobilinogen, Specific Gravity in urine. | Rapid Response | BTNX INC |
37 | 00722066000380 | U7.1-1S100 | U7.1-1S100 | Rapid Response 7 Parameter Urinalysis Reagent Strips (GLU/BLD/LEU/PRO/NIT/KET/PH Rapid Response 7 Parameter Urinalysis Reagent Strips (GLU/BLD/LEU/PRO/NIT/KET/PH) - 100 tests/ kit are for qualitative/ semi-quantitative determination of Glucose, Blood, Leukocytes, Protein, Nitrite, Ketone and pH in urine. | Rapid Response | BTNX INC |
38 | 00722066000335 | U-KET-1S100 | U-KET-1S100 | Rapid Response 1 Parameter Urinalysis Reagent Strips (Ketone) - 100 strips/ kit Rapid Response 1 Parameter Urinalysis Reagent Strips (Ketone) - 100 strips/ kit are for the qualitative or semi-quantitative detection of Ketone in urine. | Rapid Response | BTNX INC |
39 | 00695684591007 | 59100 | Dipstick reagent strips for the qualitative detection of the following : Glucose Dipstick reagent strips for the qualitative detection of the following : Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, and Nitrite in Urine. | AIMSTRIP US-9 | GERMAINE LABORATORIES, INC | |
40 | 00695684551001 | 55100 | Dipstick reagent strips for the qualitative detection of the following : Blood, Dipstick reagent strips for the qualitative detection of the following : Blood, Glucose, Protein, Ketone and pH in Urine. | AIMSTRIP US-5 | GERMAINE LABORATORIES, INC | |
41 | 00695684511111 | 51111 | AIMSTRIP US-11 | GERMAINE LABORATORIES, INC | ||
42 | 00695684511005 | 51100 | Dipstick reagent strips for the qualitative detection of the following : Glucose Dipstick reagent strips for the qualitative detection of the following : Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite and Leukocytes in Urine. | AIMSTRIP 10-SG | GERMAINE LABORATORIES, INC | |
43 | 00695684501211 | 50121 | Dipstick reagent strips for the qualitative detection of Ketone in Urine. | AIMSTRIP US-K | GERMAINE LABORATORIES, INC | |
44 | 00695684131005 | 13100 | Tablet test for the detection of ketones (acetoacetic acid and acetone) in urine Tablet test for the detection of ketones (acetoacetic acid and acetone) in urine, serum, plasma, and whole blood. Similar to Acetest, trademark used by Bayer Healthcare, LLC. | AIMTAB KETONE TABLETS | GERMAINE LABORATORIES, INC | |
45 | 00682607200412 | U031-111 | Mission Urinalysis Reagent Strips (ASC/GLU/BIL/KET/SG/BLO/PH/PRO/URO/NIT/LEU) | Mission Urinalysis Reagent Strips | ACON LABORATORIES, INC. | |
46 | 00682607200405 | U031-101 | Mission Urinalysis Reagent Strips (GLU/BIL/KET/SG/BLO/PH/PRO/URO/NIT/LEU) | Mission Urinalysis Reagent Strips | ACON LABORATORIES, INC. | |
47 | 00682607200399 | U031-091 | Mission Urinalysis Reagent Strips (GLU/BIL/KET/SG/BLO/PH/PRO/URO/NIT) | Mission Urinalysis Reagent Strips | ACON LABORATORIES, INC. | |
48 | 00682607200382 | U031-081 | Mission Urinalysis Reagent Strips (PH/GLU/BIL/PRO/URO/NIT/LEU/KET) | Mission Urinalysis Reagent Strips | ACON LABORATORIES, INC. | |
49 | 00682607200368 | U031-081 | Mission Urinalysis Reagent Strips (GLU/KET/SG/BLO/PH/PRO/NIT/LEU) | Mission Urinalysis Reagent Strips | ACON LABORATORIES, INC. | |
50 | 00682607200351 | U031-081 | Mission Urinalysis Reagent Strips (GLU/BIL/KET/BLO/PH/PRO/URO/NIT) | Mission Urinalysis Reagent Strips | ACON LABORATORIES, INC. |