No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 10758750034895 | 6177750 | 6177750 | VITROS Immunodiagnostic ProductsAFP Calibrators | JIS | Calibrator, primary | 2 | VITROS |
2 | 10758750034819 | 6177745 | 6177745 | VITROS Immunodiagnostic Products AFP Reagent Pack | LOJ | KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER | 2 | VITROS |
3 | 10758750034659 | 6199330 | 6199330 | VITROS Immunodiagnostic ProductsProlactin Calibrators | JIS | Calibrator, primary | 2 | VITROS |
4 | 10758750034420 | 6199961 | 6199961 | VITROS Immunodiagnostic Products Anti-SARS-COV-2 IgG Quantitative Calibrator | QKO | Reagent, coronavirus serological | VITROS | |
5 | 10758750034413 | 6199960 | 6199960 | VITROS Immunodiagnostic Products Anti-SARS-COV-2 IgG Quantitative Reagent Pack | QKO | Reagent, coronavirus serological | VITROS | |
6 | 10758750034321 | 6199337 | 6199337 | VITROS Immunodiagnostic Products Prolactin Reagent Pack | CFT | RADIOIMMUNOASSAY, PROLACTIN (LACTOGEN) | 1 | VITROS |
7 | 10758750034314 | 6199336 | 6199336 | VITROS Immunodiagnostic Products CK-MB Reagent Pack | JHX | FLUOROMETRIC METHOD, CPK OR ISOENZYMES | 2 | VITROS |
8 | 10758750033409 | 6199924 | 6199924 | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Controls | QKO | Reagent, coronavirus serological | VITROS | |
9 | 10758750033393 | 6199923 | 6199923 | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrator | QKO | Reagent, coronavirus serological | VITROS | |
10 | 10758750033386 | 6199922 | 6199922 | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack | QKO | Reagent, coronavirus serological | VITROS | |
11 | 10758750033379 | 6199921 | 6199921 | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Controls | QKO | Reagent, coronavirus serological | VITROS | |
12 | 10758750033362 | 6199920 | 6199920 | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator | QKO | Reagent, coronavirus serological | VITROS | |
13 | 10758750033355 | 6199919 | 6199919 | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack | QKO | Reagent, coronavirus serological | VITROS | |
14 | 10758750033317 | 6192256 | 6192256 | VITROS Immunodiagnostic Products NT-proBNP II Calibrators | JIT | Calibrator, secondary | 2 | VITROS |
15 | 10758750033300 | 6192255 | 6192255 | VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack | NBC | Test, natriuretic peptide | 2 | VITROS |
16 | 10758750033294 | 6195575 | 6195575 | VITROS Immunodiagnostic Products BRAHMS PCT Calibrator | PMT | Device to detect and measure procalcitonin (PCT) in human clinical specimens | 2 | VITROS |
17 | 10758750033287 | 6197735 | 6197735 | VITROS Immunodiagnostic Products BRAHMS PCT Reagent Pack | PMT | Device to detect and measure procalcitonin (PCT) in human clinical specimens | 2 | VITROS |
18 | 10758750033195 | 691 2265 | 691 2265 | VITROS Immunodiagnostic Products HIV Combo Controls (Anti-HIV-1 group O) | OHQ | Multi-analyte controls unassayed | 1 | VITROS |
19 | 10758750033171 | 691 2263 | 691 2263 | VITROS Immunodiagnostic Products HIV Combo Controls (HIV p24 Antigen) | OHQ | Multi-analyte controls unassayed | 1 | VITROS |
20 | 10758750033164 | 691 2261 | 691 2261 | VITROS Immunodiagnostic Products HIV Combo Controls (Negative, Anti-HIV-1, Anti-HIV-2) | OHQ | Multi-analyte controls unassayed | 1 | VITROS |
21 | 10758750032945 | 6905561 | 6905561 | VITROS Immunodiagnostic Products BRAHMS PCT Range Verifiers | PMT | Device to detect and measure procalcitonin (PCT) in human clinical specimens | 2 | VITROS |
22 | 10758750032938 | 6905560 | 6905560 | VITROS Immunodiagnostic Products BRAHMS PCT Controls | PMT | Device to detect and measure procalcitonin (PCT) in human clinical specimens | 2 | VITROS |
23 | 10758750032068 | 6844425 | 6844425 | VITROS Immunodiagnostic Products Insulin Reagent Pack | CFP | RADIOIMMUNOASSAY, IMMUNOREACTIVE INSULIN | 1 | VITROS |
24 | 10758750032051 | 6844424 | 6844424 | VITROS Immunodiagnostic Products C-peptide Calibrators | JIT | Calibrator, secondary | 2 | VITROS |
25 | 10758750032044 | 6844426 | 6844426 | VITROS Immunodiagnostic Products Insulin Calibrators | JIT | Calibrator, secondary | 2 | VITROS |
26 | 10758750032037 | 6844423 | 6844423 | VITROS Immunodiagnostic Products C-peptide Reagent Pack | JKD | RADIOIMMUNOASSAY, C-PEPTIDES OF PROINSULIN | 1 | VITROS |
27 | 10758750031597 | 6842782 | 6842782 | VITROS Immunodiagnostic Products HIV Combo Calibrator | MZF | Test, hiv detection | 2 | VITROS |
28 | 10758750031580 | 6842781 | 6842781 | VITROS Immunodiagnostic Products HIV Combo Reagent Pack | MZF | Test, hiv detection | 2 | VITROS |
29 | 10758750030217 | 6844056 | 6844056 | VITROS Immunodiagnostic Products25-OH Vitamin D Total Reagent Pack | MRG | SYSTEM, TEST, VITAMIN D | 2 | VITROS |
30 | 10758750030200 | 6844055 | 6844055 | VITROS Immunodiagnostic Products25-OH Vitamin D Total Calibrators | JIT | CALIBRATOR, SECONDARY | 2 | VITROS |
31 | 10758750009541 | 1681543 | 1681543 | VITROS Immunodiagnostic Products Cortisol Calibrators | JIS | CALIBRATOR, PRIMARY | 2 | VITROS |
32 | 10758750009411 | 1619360 | 1619360 | VITROS Immunodiagnostic Products Anemia Controls | JJY | Multi-analyte controls, all kinds (assayed) | 1 | VITROS |
33 | 10758750009404 | 1614965 | 1614965 | VITROS Immunodiagnostic Products Total T3 Calibrators | JIS | CALIBRATOR, PRIMARY | 2 | VITROS |
34 | 10758750009367 | 1540525 | 1540525 | VITROS Immunodiagnostic Products Vitamin B12 Calibrators | CDD | RADIOASSAY, VITAMIN B12 | 2 | VITROS |
35 | 10758750009237 | 1513266 | 1513266 | VITROS Immunodiagnostic Products Folate Reagent Pack 1/2 | CGN | ACID, FOLIC, RADIOIMMUNOASSAY | 2 | VITROS |
36 | 10758750009213 | 1487289 | 1487289 | VITROS Immunodiagnostic Products TSH Calibrators | JIT | CALIBRATOR, SECONDARY | 2 | VITROS |
37 | 10758750009145 | 1471481 | 1471481 | VITROS Immunodiagnostic Products T3 Uptake Reagent Pack | KHQ | RADIOASSAY, TRIIODOTHYRONINE UPTAKE | 2 | VITROS |
38 | 10758750009138 | 1453489 | 1453489 | VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack 1/2 | CDD | RADIOASSAY, VITAMIN B12 | 2 | VITROS |
39 | 10758750009077 | 1435205 | 1435205 | VITROS Immunodiagnostic Products Testosterone Reagent Pack | CDZ | RADIOIMMUNOASSAY, TESTOSTERONES AND DIHYDROTESTOSTERONE | 1 | VITROS |
40 | 10758750009053 | 1420025 | 1420025 | VITROS Immunodiagnostic Products Metabolism Controls | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | VITROS |
41 | 10758750009015 | 1410646 | 1410646 | VITROS Immunodiagnostic Products Total Thyroid Controls | JJY | Multi-analyte controls, all kinds (assayed) | 1 | VITROS |
42 | 10758750008995 | 1393396 | 1393396 | VITROS Immunodiagnostic Products Total T4 Calibrators | JIS | CALIBRATOR, PRIMARY | 2 | VITROS |
43 | 10758750008971 | 1387000 | 1387000 | VITROS Immunodiagnostic Products Free T4 Reagent Pack | CEC | RADIOIMMUNOASSAY, FREE THYROXINE | 2 | VITROS |
44 | 10758750008926 | 1372101 | 1372101 | VITROS Immunodiagnostic Products Anti-HAV IgM Calibrator | LOL | Hepatitis a test (antibody and igm antibody) | 2 | VITROS |
45 | 10758750008902 | 1350198 | 1350198 | VITROS Immunodiagnostic Products LH Reagent Pack | CEP | RADIOIMMUNOASSAY, LUTEINIZING HORMONE | 1 | VITROS |
46 | 10758750008834 | 1322528 | 1322528 | VITROS Immunodiagnostic Products Total T3 Reagent Pack | CDP | RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE | 2 | VITROS |
47 | 10758750008810 | 1318930 | 1318930 | VITROS Immunodiagnostic ProductsEstradiol Calibrators | JIS | CALIBRATOR, PRIMARY | 2 | VITROS |
48 | 10758750008803 | 1315654 | 1315654 | VITROS Immunodiagnostic Products Free Thyroid Controls | JJY | Multi-analyte controls, all kinds (assayed) | 1 | VITROS |
49 | 10758750008797 | 1315589 | 1315589 | VITROS Immunodiagnostic Products Free T3 Reagent Pack | CDP | RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE | 2 | VITROS |
50 | 10758750008766 | 1311075 | 1311075 | VITROS Immunodiagnostic Products Folate Calibrators | JIS | CALIBRATOR, PRIMARY | 2 | VITROS |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00605388780065 | 780006 | ReliOn Premier Control Solution Level 2 contains a known amount of glucose that ReliOn Premier Control Solution Level 2 contains a known amount of glucose that reacts with the test strips and is used to check if the meter and test strips are working correctly as a system and you are testing correctly. Compare the control solution test result with the range printed on the test strip bottle label. (Primary UPC# 605388780065 is used as the assigned UDI for the Class I device.) | ReliOn™ Premier Control Solution Level 2 | WAL-MART STORES, INC. | |
2 | 00605388780058 | 780005 | ReliOn Premier Control Solution Level 1 contains a known amount of glucose that ReliOn Premier Control Solution Level 1 contains a known amount of glucose that reacts with the test strips and is used to check if the meter and test strips are working correctly as a system and you are testing correctly. Compare the control solution test result with the range printed on the test strip bottle label. (Primary UPC# 605388780058 is used as the assigned UDI for the Class I device.) | ReliOn™ Premier Control Solution Level 1 | WAL-MART STORES, INC. | |
3 | 00605388710055 | 710005 | ReliOn Confirm/Micro Control contains a known amount of glucose that reacts with ReliOn Confirm/Micro Control contains a known amount of glucose that reacts with the test strips and is used to check if the meter and test strips are working correctly. Compare the control solution test result with the range printed on the test strip bottle. | ReliOn™ Confirm/Micro Control | WAL-MART STORES, INC. | |
4 | 00389167362108 | 036210 | 036210 | UniStrip Control Solution Low 4mL | UniStrip Control Solution Low | UNISTRIP TECHNOLOGIES, LLC |
5 | 00389154000693 | 3L-10-16003F | 3L-10-16003F | GL GoodLife Blood Glucose Test Strip(Content:50 strips and 50 lancet.) | GL GoodLife AC11-Strip(foil) | HMD BIOMEDICAL INC. |
6 | 00389154000679 | 3K-01-16003S | 3K-01-16003S | GL GoodLife Blood Glucose Meter (single patient home use) | GL GoodLife Blood Glucose Meter AC-11 | HMD BIOMEDICAL INC. |
7 | 00389154000631 | AC-11 AC302 | 3K-01-16003R | GL GoodLife AC-302 Blood Glucose Meter (include GCS ),Standard type. | GL GoodLife AC-302 Blood Glucose Monitoring System | HMD BIOMEDICAL INC. |
8 | 00389154000570 | AC-11 vial | 3S-01-16003C | GL GoodLife AC300 Blood Glucose Test Strip | GL GoodLife AC300 Test Strip-Vial | HMD BIOMEDICAL INC. |
9 | 00389154000549 | 3C-01-160032 | 3C-01-160032 | GL GoodLife Glucose Control Solution | GL GoodLife Glucose Control Solutions | HMD BIOMEDICAL INC. |
10 | 00389154000440 | GL GCS | 3C-01-810032 | GL GoodLife Glucose Control Solution(Level 1) for use with GL GoodLife Blood Glu GL GoodLife Glucose Control Solution(Level 1) for use with GL GoodLife Blood Glucose System | GL GoodLife Glucose Control Solution(Level 1) | HMD BIOMEDICAL INC. |
11 | 00389154000389 | AC11 | 3K-01-16003H | Rosie SmartMeter Blood Glucose Monitoring System | Rosie SmartMeter | HMD BIOMEDICAL INC. |
12 | 00389154000372 | IG01 | 3K-01-810037 | GL GoodLife Blood Glucose Monitoring System(Cloudia) | GL GoodLife | HMD BIOMEDICAL INC. |
13 | 00389154000266 | IG STRIP FOIL | 3L-10-810037 | GL GoodLife Blood Glucose Test Strip-Foil For Cloudia | GL GoodLife Blood Glucose Test Strip-Foil For Cloudia | HMD BIOMEDICAL INC. |
14 | 00389154000204 | 3L-10-16003A | 3L-10-16003A | GL GoodLife Blood Glucose Test Strip(Foil) | GL GoodLife Blood Glucose Test Strip AC (50 Strips&lancets in foil) | HMD BIOMEDICAL INC. |
15 | 00389154000075 | AC11-Foil | 3K-01-16003C | GoodLife AC Blood Glucose Test Strips | GL GoodLife Blood Glucose Test Strip AC (50ct in foil) | HMD BIOMEDICAL INC. |
16 | 00386100001933 | 10799 | 10799 | CRP Quality Control Kit Level 3 for use with EasyRA Analyzer | CRP Quality Control Kit Level 3 | MEDICA CORPORATION |
17 | 00386100001926 | 10798 | 10798 | CRP Quality Control Kit Level 2 for use with EasyRA Analyzer | CRP Quality Control Kit Level 2 | MEDICA CORPORATION |
18 | 00386100001919 | 10797 | 10797 | CRP Quality Control Kit Level 1 for use with EasyRA Analyzer | CRP Quality Control Kit Level 1 | MEDICA CORPORATION |
19 | 00386100001902 | 10796 | 10796 | HbA1c Quality Control Kit Level 2 for use with EasyRA Analyzer | HbA1c Quality Control Kit Level 2 | MEDICA CORPORATION |
20 | 00386100001896 | 10795 | 10795 | HbA1c Quality Control Kit Level 1 for use with EasyRA Analyzer | HbA1c Quality Control Kit Level 1 | MEDICA CORPORATION |
21 | 00385543764023 | 8000-03764 | Control Solution, AgaMatrix, Combo Normal and High | AgaMatrix | AGAMATRIX, INC. | |
22 | 00385480547901 | 1.86 | 54790 | Statstrip Glucose Meter with Battery and Quick Reference Guide | STATSTRIP | NOVA BIOMEDICAL CORPORATION |
23 | 00385480536653 | PRIME ABG | 53665 | Remanufactured Prime ABG w/ Scanner Analyzer | STAT PROFILE | NOVA BIOMEDICAL CORPORATION |
24 | 00385480536554 | PRIME ABG | 53655 | Prime ABG w/ Scanner Analyzer | STAT PROFILE | NOVA BIOMEDICAL CORPORATION |
25 | 00385480534215 | PRIME ABG | 53421 | Remanufactured PRIME ABG Analyzer | STAT PROFILE | NOVA BIOMEDICAL CORPORATION |
26 | 00385480528559 | PRIME ABG | 52855 | Prime ABG w/ Scanner Analyzer | STAT PROFILE | NOVA BIOMEDICAL CORPORATION |
27 | 00385480517072 | 1.0 | 51707 | StatStrip GLU Meter with Quick Reference Guide Remanufactured | STATSTRIP | NOVA BIOMEDICAL CORPORATION |
28 | 00385480475549 | STATSTRIP LAC | 47554 | Nova StatStrip LAC Control, Level 2 | NOVA | NOVA BIOMEDICAL CORPORATION |
29 | 00385480475532 | STATSTRIP LAC | 47553 | Nova StatStrip LAC Control, Level 1 | NOVA | NOVA BIOMEDICAL CORPORATION |
30 | 00385480471435 | 1.0 | 47143 | StatStrip Glu Meter and Quick Reference Guide Remanufactured | STATSTRIP | NOVA BIOMEDICAL CORPORATION |
31 | 00385480467995 | Ejector | 46799 | StatStrip Xpress GLU Meter with Battery and Quick Reference Guide | STATSTRIP | NOVA BIOMEDICAL CORPORATION |
32 | 00385480458863 | 1.0 | 45886 | StatStrip GLU Meter with Quick Reference Guide Remanufactured | STATSTRIP | NOVA BIOMEDICAL CORPORATION |
33 | 00385480458245 | Plus | 45824 | Nova Max Plus Blood Glucose Monitoring System | Nova Max | NOVA BIOMEDICAL CORPORATION |
34 | 00385480440370 | Creatinine | 44037 | StatSensor Creat Linearity Level 1 - 5 | StatSensor | NOVA BIOMEDICAL CORPORATION |
35 | 00385480439237 | 1.0 | 43923 | StatSensor Creat Control Level 3 | STATSENSOR | NOVA BIOMEDICAL CORPORATION |
36 | 00385480439220 | 1.0 | 43922 | StatSensor Creat Control Level 2 | STATSENSOR | NOVA BIOMEDICAL CORPORATION |
37 | 00385480439213 | 1.0 | 43921 | StatSensor Creat Control Level 1 | STATSENSOR | NOVA BIOMEDICAL CORPORATION |
38 | 00385480437738 | 1.0 | 43773 | StatStrip GLU Meter and Quick Reference Guide Remanufactured | StatStrip | NOVA BIOMEDICAL CORPORATION |
39 | 00385480434461 | GLU | 43446 | Nova Max Glucose Normal Glucose Control Solution | NOVA MAX | NOVA BIOMEDICAL CORPORATION |
40 | 00385480434362 | Plus | 43436 | Nova Max Plus Blood Glucose Monitoring System | Nova Max | NOVA BIOMEDICAL CORPORATION |
41 | 00385480434355 | Plus | 43435 | Nova Max Plus Plus Blood Glucose Monitoring System | Nova Max | NOVA BIOMEDICAL CORPORATION |
42 | 00385480421737 | Statstrip/StatStrip Xpress | 42173 | StatStrip StatStrip Xpress GLU Linearity Level 1-5 | StatStrip | NOVA BIOMEDICAL CORPORATION |
43 | 00385480417433 | STATSTRIP XPRESS GLU | 41743 | StatStrip StatStrip Xpress GLU Control Level 3 | NOVA | NOVA BIOMEDICAL CORPORATION |
44 | 00385480417426 | STATSTRIP XPRESS GLU | 41742 | StatStrip StatStrip Xpress GLU Control Level 2 | NOVA | NOVA BIOMEDICAL CORPORATION |
45 | 00385480417419 | STATSTRIP XPRESS GLU | 41741 | StatStrip StatStrip Xpress GLU Control Level 1 | NOVA | NOVA BIOMEDICAL CORPORATION |
46 | 00384849903105 | 990310 | 990310 | Prodigy Control Solution Low 4mL | Prodigy Control Solution Low | PRODIGY DIABETES CARE, LLC |
47 | 00384840719507 | 071950 | 071950 | Prodigy Voice Blood Glucose Monitoring System (KIT) | Prodigy Voice Blood Glucose Monitoring System | PRODIGY DIABETES CARE, LLC |
48 | 00384840533509 | 053350 | 053350 | Prodigy Control Solution High 4mL | Prodigy Control Solution High | PRODIGY DIABETES CARE, LLC |
49 | 00384840533103 | 053310 | 053310 | Prodigy Control Solution Low 4mL | Prodigy Control Solution Low | PRODIGY DIABETES CARE, LLC |
50 | 00384840519008 | 051900 | 051900 | Prodigy Voice Blood Glucose Monitoring System (KIT) | Prodigy Voice Blood Glucose Monitoring System | PRODIGY DIABETES CARE, LLC |