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 | 08809301161036 | PS-004 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | Gmate® Blood Glucose Test Strips | |||
6 | 08809301162026 | PC-003 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Gmate® Control Solution Level 3 | ||
7 | 08809301161760 | PS-004 | NBW,CGA | System, Test, Blood Glucose, Over The Counter,Glucose Oxidase, Glucose | Pip Blood Glucose Test Strips | |||
8 | 08809301168059 | GT-C01 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | GlucoTrack Solution Level 1 | ||
9 | 08809301160152 | PG-200 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | Gmate® mini Blood Glucose Monitoring System | ||
10 | 08809301160114 | PG-200 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | Gmate® mini Blood Glucose Monitoring System | ||
11 | 08809301160015 | PG-200 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | Gmate® mini Blood Glucose Monitoring System | ||
12 | 08809301160862 | PG-310 | NBW,CGA | System, Test, Blood Glucose, Over The Counter,Glucose Oxidase, Glucose | 2 | Pip Blood Glucose Monitoring System | ||
13 | 08809301160213 | PG-301 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | Gmate® VOICE Blood Glucose Monitoring System | ||
14 | 08809301160138 | PG-301 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | Gmate® VOICE Blood Glucose Monitoring System | ||
15 | 08809301160084 | PG-301 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | Gmate® VOICE Blood Glucose Monitoring System | ||
16 | 08809301168066 | GT-C02 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | GlucoTrack Solution Level 2 | ||
17 | 08809301168134 | GT-101 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | GlucoTrack SMART Blood Glucose Monitoring System | ||
18 | 08809301168127 | GT-101 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | GlucoTrack SMART Blood Glucose Monitoring System | ||
19 | 08809301168110 | GT-101 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | GlucoTrack SMART Blood Glucose Monitoring System | ||
20 | 08809301162057 | PC-001 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Gmate® Control Solution Level 1 | ||
21 | 08809301162019 | PC-002 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Gmate® Control Solution Level 2 | ||
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 | 04560189213159 | N//A | AIA-PACK 25-OH Vitamin D CONTROL SET | TOSOH CORPORATION | ||
2 | 04560189212909 | N/A | 0025428 | AIA-PACK BNP CONTROL SET | TOSOH CORPORATION | |
3 | 04560189212800 | N/A | AIA-PACK Homocysteine Control Set | TOSOH CORPORATION | ||
4 | 04560189212299 | N/A | AIA-PACK bHCG Calibration Verification Test Set | TOSOH CORPORATION | ||
5 | 04560189212282 | N/A | AIA-PACK PRL CALIBRATION VERIFICATION TEST SET | TOSOH CORPORATION | ||
6 | 04560189212275 | N/A | AIA-PACK PAP CALIBRATION VERIFICATION TEST SET | TOSOH CORPORATION | ||
7 | 04560189212268 | N/A | AIA-PACK FSH Calibration Verification Test Set | TOSOH CORPORATION | ||
8 | 04560189212237 | N/A | AIA-PACK AFP Calibration Verification Test Set | TOSOH CORPORATION | ||
9 | 04560189211971 | n/a | AIA-PACK PA CALIBRATION VERIFICATION TEST SET | TOSOH CORPORATION | ||
10 | 04560189210875 | N/A | AIA-PACK Intact PTH CONTROL SET | TOSOH CORPORATION | ||
11 | H628A569341 | A56934 | A56934 | The Access Hybritech p2PSA QC are tri-level controls intended for monitoring sys The Access Hybritech p2PSA QC are tri-level controls intended for monitoring system performance of immunoenzymatic procedures for the quantitative measurement of [-2]proPSA isoform of Prostate Specific Antigen (PSA) using the Access Immunoassay Systems. | Access Hybritech p2PSA QC | BECKMAN COULTER, INC. |
12 | H628372191 | 37219 | 37219 | The Access Hybritech free PSA QC are bi-level controls intended for monitoring s The Access Hybritech free PSA QC are bi-level controls intended for monitoring system performance of immunoenzymatic procedures for the quantitative measurement of free Prostate Specific Antigen (free PSA) using the Access Immunoassay Systems. | Access Hybritech free PSA QC | BECKMAN COULTER, INC. |
13 | H628372091 | 37209 | 37209 | The Access Hybritech PSA QC are tri-level controls intended for monitoring syste The Access Hybritech PSA QC are tri-level controls intended for monitoring system performance of immunoenzymatic procedures for the quantitative measurement of total Prostate Specific Antigen (PSA) using the Access Immunoassay Systems. | Access Hybritech PSA QC | BECKMAN COULTER, INC. |
14 | 04260236851159 | 3S-01-160037 | 3S-01-160037 | PRECICHEK AutoCode Blood Glucose ACH vial packed test strip. | PRECICHEK AutoCode vial packed test strip | HMD BIOMEDICAL INC. |
15 | 04260236851142 | 3L-10-16003B | 3L-10-16003B | PRECICHEK AutoCode Blood Glucose ACH foil packed test strip | PRECICHEK AutoCode foil packed test strip | HMD BIOMEDICAL INC. |
16 | 04260236851111 | 3L-10-16003H | 3L-10-16003H | PRECICHEK AutoCode Blood Glucose ACH foil packed test strip | PRECICHEK AutoCode foil packed test strip | HMD BIOMEDICAL INC. |
17 | 04260236851067 | 3L-10-16003G | 3L-10-16003G | PRECICHEK AutoCode Blood Glucose ACH foil packed test strip | PRECICHEK AutoCode foil packed test strip | HMD BIOMEDICAL INC. |
18 | 04260236851050 | 3K-01-16003X | 3K-01-16003X | PRECICHEK AC300 Blood Glucose Monitoring System. | PRECICHEK AC300 | HMD BIOMEDICAL INC. |
19 | 04260236850916 | 3S-01-16003F | 3S-01-16003F | PRECICHEK AutoCode Blood Glucose ACH vial packed test strip. | PRECICHEK AutoCode vial packed test strip | HMD BIOMEDICAL INC. |
20 | 04260236850664 | 3L-10-16003D | 3L-10-16003D | PRECICHEK AutoCode Blood Glucose ACH foil packed test strip | PRECICHEK AutoCode foil packed test strip | HMD BIOMEDICAL INC. |
21 | 04260236850619 | 3K-01-16003A | 3K-01-16003A | PRECICHEK AutoCode AC302 Blood Glucose Monitoring System. | PRECICHEK AutoCode AC302 | HMD BIOMEDICAL INC. |
22 | 04260236850411 | 3S-01-160032 | 3S-01-160032 | PRECICHEK AutoCode Blood Glucose ACH vial packed test strip | PRECICHEK AutoCode vial packed test Strip | HMD BIOMEDICAL INC. |
23 | 04260236850329 | 3L-10-160031 | 3L-10-160031 | PRECICHEK AutoCode Blood Glucose ACH foil packed test strip | PRECICHEK AutoCode foil packed test strip | HMD BIOMEDICAL INC. |
24 | 04250317546517 | 0318 | 0318 | MassCheck® Methylmalonic Acid Urine Control Level II | Urine Control | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
25 | 04250317546500 | 0317 | 0317 | MassCheck® Methylmalonic Acid Urine Control Level I | Urine Control | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
26 | 04250317546494 | 0315 | 0315 | MassCheck® Methylmalonic Acid Plasma Control Level II | Pasma Control | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
27 | 04250317546487 | 0314 | 0314 | MassCheck® Methylmalonic Acid Plasma Control Level I | Plasma Control | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
28 | 04250317544162 | 0096 | 0096 | Plasma Control Level II, Malondialdeyhde in plasma/serum | Plasma Control | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
29 | 04250317544148 | 0093 | 0093 | Plasma Control Level II, Coenzyme Q10 | Plasma Control | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
30 | 04250317544100 | 0078 | 0078 | Whole blood control Level I, Glutathione in whole blood | Whole Blood Control | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
31 | 04250317544063 | 0095 | 0095 | Plasma Control Level I, Malondialdeyhde in plasma/serum | Plasma Control | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
32 | 04250317544056 | 0076 | 0076 | Plasma Control Level II Vitamin C in plasma/serum | Plasma Control | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
33 | 04250317544049 | 0075 | 0075 | Plasma Control Level I, Vitamin C in plasma/serum | Plasma Control | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
34 | 04250317544032 | 0092 | 0092 | Plasma Control Level I, Coenzyme Q10 | Plasma Control | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
35 | 04250317543929 | 0073 | 0073 | Plasma Control Level II, Homocysteine in plasma/serum | Plasma Control | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
36 | 04250317543912 | 0072 | 0072 | Plasma Control Level I, Homocysteine in plasma/serum | Plasma Control | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
37 | 04250317543462 | 0027 | 0027 | Serum Control Level II, ß-Carotene in serum/plasma | Serum Control | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
38 | 04250317543455 | 0026 | 0026 | Serum Control Level I, ß-Carotene in serum/plasma | Serum Control | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
39 | 04250317534361 | 0313 | 0313 | MassCheck® Methylmalonic Acid Plasma Control Bi-Level | Plasma Control Bi-Level | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
40 | 04250317526038 | 0316 | 0316 | MassCheck® Methylmalonic Acid Urine Control Bi-Level | Urine Control Bi-Level | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
41 | 04250317515650 | 0094 | 0094 | Plasma Control Bi-Level, Malondialdeyhde in plasma/serum | Plasma Control Bi-Level | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
42 | 04250317515520 | 0091 | 0091 | Plasma Control Bi-Level, Coenzyme Q10 | Plasma Control Bi-Level | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
43 | 04250317515094 | 0077 | 0077 | Whole blood control Bi-Level Glutathione in whole blood | Whole Blood Control Bi-Level | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
44 | 04250317515049 | 0074 | 0074 | Plasma Control Bi-Level, Vitamin C in plasma/serum | Plasma Control Bi-Level | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
45 | 04250317514974 | 0071 | 0071 | Plasma Control Bi-Level Homocysteine in plasma/serum | Plasma Control Bi-Level | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
46 | 04250317504234 | 0025 | 0025 | Serum Control Bi-Level, ß-Carotene in serum/plasma | Serum Control Bi-Level | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
47 | 04051839002921 | 595409943084 | 595409943084 | For use as controls in quantative procedures for β-Hydroxybutyrate | β-Hydroxybutyrate 21 Bi-Level Controls | DIASYS DIAGNOSTIC SYSTEMS GMBH |
48 | 04051839002914 | 595709943085 | 595709943085 | For use as controls in quantitative procedures for β-Hydroxybutyrate | β-Hydroxybutyrate 21 Tri-Level Controls | DIASYS DIAGNOSTIC SYSTEMS GMBH |
49 | 04049325014879 | 30108902 | 30108902 | Unassayed Testosterone QC Material - 20 mL | Unassayed Testosterone QC Material | IBL INTERNATIONAL GMBH |
50 | 04049325006546 | RE62039. | RE62039. | Testosterone Luminescence Immunoassay - 10 x 96 Determinations | Testosterone Luminescence Immunoassay | IBL INTERNATIONAL GMBH |