No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00817238011643 | 98232 | Cardiac Calibration Verifiers for Beckman Systems | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Cardiac Calibration Verifiers for Beckman Systems | |
2 | 00817238011605 | 91490 | Cardiac Control Complete +TnT level 1 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Cardiac Control Complete +TnT level 1 | |
3 | 00817238011551 | 83638 | Vitamin D | Vitamin D | ||||
4 | 00817238011391 | R82042 | BUN Rate Reagent | CDG | Chromatography Separation/Zimmerman 17-Ketogenic Steroids | 1 | BUN Rate Reagent | |
5 | 00817238011322 | 85621 | Hemoglobin A1C Reagent | LCP | Assay, Glycosylated Hemoglobin | 2 | Hemoglobin A1C Reagent | |
6 | 00817238011117 | R85168 | Phosphorous Reagent | Phosphorous Reagent | ||||
7 | 00817238011032 | R85321 | Fructosamine Calibrator | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Fructosamine Calibrator | |
8 | 00817238010486 | 97201 | DipStrip Urinalysis Control Bi-Level | JJW | Urinalysis Controls (Assayed And Unassayed) | 1 | DipStrip Urinalysis Control Bi-Level | |
9 | 00817238010394 | 91819 | DIABETES CONTROL SAMPLE PACK | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | DIABETES CNTL, Smpl, 1x2x0.5mL | |
10 | 00817238010271 | 91501 | LIQUID QC LIPID CONTROL LEVEL | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | LIQUID QC LIPID CONTROL LEVEL | |
11 | 00817238010103 | 91303 | Tumor Marker Control level 3 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Tumor Marker Control level 3 | |
12 | 00817238011582 | 93221 | WHOLE BLD VOLATILES CONTROL LEVEL 1 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | WHOLE BLD VOLATILES CONTROL LEVEL 1 | |
13 | 00817238010783 | 85962 | Hemoglobin A1c Calibrators | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Hemoglobin A1c Calibrators | |
14 | 00817238010028 | 98602 | LiniCAL Cardiac CalVer for Abbott Systems, Level ALiniCAL Cardiac CalVer for Abb LiniCAL Cardiac CalVer for Abbott Systems, Level ALiniCAL Cardiac CalVer for Abbott Systems, Level BLiniCAL Cardiac CalVer for Abbott Systems, Level CLiniCAL Cardiac CalVer for Abbott Systems, Level DLiniCAL Cardiac CalVer for Abbott Systems, Level E | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Cardiac CalVer for Abbott Systems, Level A-E | |
15 | 00817238011575 | 93212 | WHOLE BLOOD ETHANOL CONTROL LEVEL 2 | DKC | Alcohol Control Materials | 1 | WHOLE BLOOD ETHANOL CONTROL LEVEL 2 | |
16 | 00817238011568 | 93211 | WHOLE BLOOD ETHANOL CONTROL LEVEL1 | DKC | Alcohol Control Materials | 1 | WHOLE BLOOD ETHANOL CONTROL LEVEL1 | |
17 | 00817238011513 | 91444 | LQC Cardiac Control CS, Tri-level kit | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | LQC Cardiac Control CS, Tri-level kit | |
18 | 00817238010479 | 95505 | Alcohol/Ammonia Control Bi-level | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Alcohol/Ammonia Control Bi-level | |
19 | 00817238010417 | 94102 | Immunoassay Control Level 2 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Immunoassay Control Level 2 | |
20 | 00817238010288 | 91502 | LIQUID QC LIPID CONTROL LEVEL 2 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | LIQUID QC LIPID CONTROL LEVEL 2 | |
21 | 00817238010233 | 91203 | hsCRP Serum Protein Control Level 3 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | hsCRP Serum Protein Control Level 3 | |
22 | 00817238010219 | 91201 | hsCRP Serum Protein Control Level 1 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | hsCRP Serum Protein Control Level 1 | |
23 | 00817238010202 | 91103 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | ImmuTROL Serum Protein Contrl Level 3 | ||
24 | 00817238010172 | 91105 | ImmuTROL Serum Protein Control-Bi-Level (Level 1 & 3) | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | ImmuTROL Serum Protein Control-Bi-Level (Level 1 & 3) | |
25 | 00817238010042 | 91474 | Cardiac Marker Control VS Tri-Levels | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Cardiac Marker Control VS | |
26 | 00817238011636 | 98505 | Cardiac Calibration Verifiers for Roche Systems | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Cardiac Calibration Verifiers for Roche Systems | |
27 | 00817238011148 | R85411 | Glucose UV REAGENT | CFR | Hexokinase, Glucose | 2 | Glucose UV REAGENT | |
28 | 00817238011056 | 85550 | hsCRP Wide Range Reagent | DCK | C-Reactive Protein, Antigen, Antiserum, And Control | 2 | hsCRP Wide Range Reagent | |
29 | 00817238010462 | 95502 | Alcohol/Ammonia Control level 2 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Alcohol/Ammonia Control level 2 | |
30 | 00817238010455 | 95501 | Alcohol/Ammonia Control level 1 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Alcohol/Ammonia Control level 1 | |
31 | 00817238010189 | 91101 | ImmuTROL Serum Protein Contrl Level 1 | ImmuTROL Serum Protein Contrl Level 1 | ||||
32 | 00817238010127 | 91302 | Tumor Marker Control level 2 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Tumor Marker Control level 2 | |
33 | 00817238010110 | 91301 | Tumor Marker Control level 1 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Tumor Marker Control level 1 | |
34 | 00817238010066 | 91482 | Cardiac Marker Control +TnI Level 2 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Cardiac Marker Complete Level 2 | |
35 | 00817238011612 | 91491 | Cardiac Control Complete +TnT level 2 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Cardiac Control Complete +TnT level 2 | |
36 | 00817238010677 | 98502 | Protein 2 Calibration Verifier Set for the Roche Integra | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Protein 2 Calibration Verifier Set for the Roche Integra | |
37 | 00817238010578 | R83082 | Assay Control Serum Level 1 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Assay Control Serum Level 1 | |
38 | 00817238010523 | R85528 | LIPID CALIBRATOR, LYOPHILIZED | LIPID CALIBRATOR, LYOPHILIZED | ||||
39 | 00817238010493 | 97202 | DropStrip Urinalysis Control Bi-Level | JJW | Urinalysis Controls (Assayed And Unassayed) | 1 | DropStrip Urinalysis Control Bi-Level | |
40 | 00817238010448 | 94109 | Tri-Level Immunoassay Control Minipack | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Tri-Level Immunoassay Control Minipack | |
41 | 00817238010424 | 94103 | Immunoassay Control Level 3 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Immunoassay Control Level 3 | |
42 | 00817238010387 | 91815 | DIABETES CONTROL BI-LEVEL | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | DIABETES CNTL, Bi-L | |
43 | 00817238010226 | 91202 | hsCRP Serum Protein Control Level 2 | hsCRP Serum Protein Control Level 2 | ||||
44 | 00817238010158 | 91309 | Tumor Marker Control Tri-level | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Tumor Marker Control Tri-level | |
45 | 00817238010141 | 91104 | ImmuTROL Serum Protein Contrl Tri-Level (Level 1,2 & 3) | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | ImmuTROL Serum Protein Contrl Tri-Level (Level 1,2 & 3) | |
46 | 00817238010134 | 91304 | Tumor Marker Control Tri-level | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Tumor Marker Control Tri-level | |
47 | 00817238011315 | 98303 | Protein 3 Calibration Verifier set for the BCI AU | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Protein 3 Calibration Verifier set for the BCI AU | |
48 | 00817238010684 | 98503 | Protein 3 Calibration verifier Set for the Roche Integra | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Protein 3 Calibration verifier Set for the Roche Integra | |
49 | 00817238010516 | 97204 | DipScopics Urinalysis Control Bi-Level | JJW | Urinalysis Controls (Assayed And Unassayed) | 1 | DipScopics Urinalysis Control Bi-Level | |
50 | 00817238010240 | 91204 | hsCRP Serum Protein Control Tri-Level | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | hsCRP Serum Protein Control Tri-Level |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00850011135471 | 1300wa | 1300wa | Validate 1300wa is intended for Calibration Verification/Linearity of general ch Validate 1300wa is intended for Calibration Verification/Linearity of general chemistries on automated instruments. | VALIDATE | LGC CLINICAL DIAGNOSTICS, INC. |
2 | 00850011135464 | 1100wa | 1100wa | Validate 1100wa is intended for Calibration Verification/Linearity of general ch Validate 1100wa is intended for Calibration Verification/Linearity of general chemistries on automated instruments. | VALIDATE | LGC CLINICAL DIAGNOSTICS, INC. |
3 | 00850011135440 | 508ro | VALIDATE Growth Hormone IVD Control | Validate | LGC CLINICAL DIAGNOSTICS, INC. | |
4 | 00850011135396 | 608mm | Validate ISX Multiple-type clinical chemistry analyte IVD, control | Validate | LGC CLINICAL DIAGNOSTICS, INC. | |
5 | 00850011135389 | 207ro | 207ro | Validate Body Fluids 3 is intended for quantitative determination of Calibration Validate Body Fluids 3 is intended for quantitative determination of Calibration Verification/Linearity on Automated Instruments. | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
6 | 00850011135365 | 505ro | 505ro | Validate Fertility 3 is intended for the quantitative determination of Calibrati Validate Fertility 3 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
7 | 00850011135358 | 705ab | 705ab | Validate UC5 is intended for the quantitative determination of Calibration Verif Validate UC5 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
8 | 00850011135341 | 704ab | 704ab | Validate UC4 is intended for the quantitative determination of Calibration Verif Validate UC4 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
9 | 00850011135334 | 701ab | 701ab | Validate UC1 is intended for the quantitative determination of Calibration Verif Validate UC1 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
10 | 00850011135303 | 504ab | 504ab | Validate Fertility 2 is intended for the quantitative determination of Calibrati Validate Fertility 2 is intended for the quantitative determination of Calibration Verification/Linearity of on automated instruments. | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
11 | 00850011135297 | 502ab | 502ab | Validate Fertility 1 is intended for the quantitative determination of Calibrati Validate Fertility 1 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
12 | 00850011135273 | 204ro | 204ro | Validate Diabetes is intended for the quantitative determination of Calibration Validate Diabetes is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
13 | 00850011135266 | 407ab | 407ab | Validate Tumor Markers is intended for the quantitative determination of Calibra Validate Tumor Markers is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
14 | 00850011135242 | 308ab | 308ab | Validate Anemia is intended for the quantitative determination of Calibration Ve Validate Anemia is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
15 | 00850011135235 | 308vt | 308vt | Validate Anemia is intended for the quantitative determination of Calibration Ve Validate Anemia is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
16 | 00850011135228 | 401ro | 401ro | Validate CM1 is intended for the quantitative determination of Calibration Verif Validate CM1 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
17 | 00850011135204 | 409ro | 409ro | Validate CM3 is intended for the quantitative determination of Calibration Verif Validate CM3 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
18 | 00850011135198 | 206ro | 206ro | Validate Body Fluids 2 is intended for the quantitative determination of Calibra Validate Body Fluids 2 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
19 | 00850011135181 | 901re | 901re | Validate THY is intended for the quantitative determination of Calibration Verif Validate THY is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
20 | 00850011135174 | 901bc | 901bc | Validate THY is intended for the quantitative determination of Calibration Verif Validate THY is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
21 | 00850011135167 | 706af | 706af | Validate UC6 is intended for the quantitative determination of Calibration Verif Validate UC6 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
22 | 00850011135150 | 705vt | 705vt | Validate UC5 is intended for the quantitative determination of Calibration Verif Validate UC5 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
23 | 00850011135143 | 705ro | 705ro | Validate UC5 is intended for the quantitative determination of Calibration Verif Validate UC5 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
24 | 00850011135136 | 705ri | 705ri | Validate UC5 is intended for the quantitative determination of Calibration Verif Validate UC5 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
25 | 00850011135129 | 705db | 705db | Validate UC5 is intended for the quantitative determination of Calibration Verif Validate UC5 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
26 | 00850011135112 | 705bcc | 705bcc | Validate UC5 is intended for the quantitative determination of Calibration Verif Validate UC5 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
27 | 00850011135105 | 705au | 705au | Validate UC5 is intended for the quantitative determination of Calibration Verif Validate UC5 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
28 | 00850011135099 | 704sa | 704sa | Validate UC4 is intended for the quantitative determination of Calibration Verif Validate UC4 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
29 | 00850011135082 | 704ro | 704ro | Validate UC4 is intended for the quantitative determination of Calibration Verif Validate UC4 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
30 | 00850011135075 | 704ri | 704ri | Validate UC4 is intended for the quantitative determination of Calibration Verif Validate UC4 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
31 | 00850011135068 | 704db | 704db | Validate UC4 is intended for the quantitative determination of Calibration Verif Validate UC4 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
32 | 00850011135051 | 704bc | 704bc | Validate UC4 is intended for the quantitative determination of Calibration Verif Validate UC4 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
33 | 00850011135044 | 704au | 704au | Validate UC4 is intended for the quantitative determination of Calibration Verif Validate UC4 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
34 | 00850011135037 | 703 | 703 | Validate OSMO is intended for the quantitative determination of Calibration Veri Validate OSMO is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
35 | 00850011135020 | 701vt | 701vt | Validate UC1 is intended for the quantitative determination of Calibration Verif Validate UC1 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
36 | 00850011135013 | 701ro | 701ro | Validate UC1 is intended for the quantitative determination of Calibration Verif Validate UC1 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
37 | 00850011135006 | 701ri | 701ri | Validate UC1 is intended for the quantitative determination of Calibration Verif Validate UC1 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
38 | 00847865010986 | SW4.1_V1 | 6653270E | BioPlex 2200 Anti-CCP Assay Protocol File CD, SW4.1_v1 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
39 | 00847865002295 | SW4V3 | 6653265D | U.S. IFU, Manual & CDs, Anti-CCP IFU, SW4_v3 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
40 | 00847865002288 | SW4_V3 | 6653270D | Anti-CCP Assay Protocol File CD, SW4_v3 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
41 | 00847865001366 | SW4.1V1 | 6653265E | U.S Only IFU, Manual & CDs, Anti-CCP IFU, SW4.1_v1 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
42 | 00847865000932 | 6633340 | 6633340 | HSV-1 & HSV-2 Control Lot Data | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
43 | 00847865000925 | 6633330 | 6633330 | HSV-1 & HSV-2 IgG Control Set | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
44 | 00847865000857 | 6653250 | 6653250 | Anti-CCP Reagent Pack | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
45 | 00847865000840 | 6633240 | 6633240 | Anti-CCP Control Lot Data | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
46 | 00847865000833 | 6633230 | 6633230 | Anti-CCP Control Set | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
47 | 00847865000826 | 6633220 | 6633220 | CD, BioPlex Anti-CCP Calibrator Lot Data | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
48 | 00847865000819 | 6633200 | 6633200 | Anti-CCP Calibrator Set | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
49 | 00847865000529 | 6631840 | 6631840 | Vasculitis Control Lot Data | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
50 | 00847865000512 | 6631830 | 6631830 | Vasculitis Control Set | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |