No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00847865000758 | 6632440 | 6632440 | MMRV IgG Control Lot Data | OPL,LJY,LFY,LJB | Multiplex immunoassay for measles virus, mumps virus, rubella and varicella zost Multiplex immunoassay for measles virus, mumps virus, rubella and varicella zoster virus,ENZYME LINKED IMMUNOABSORBENT ASSAY, MUMPS VIRUS,ENZYME LINKED IMMUNOABSORBENT ASSAY, VARICELLA-ZOSTER,Enzyme linked immunoabsorbent assay, rubeola IgG | 1 | BioPlex 2200 |
2 | 00847865000437 | 6631640 | 6631640 | ToRC IgG Control Lot Data | JJY | Multi-analyte controls, all kinds (assayed) | 1 | BioPlex 2200 |
3 | 00847865013017 | SW4.1V1 | 6652365A | Manual & CDs, Celiac IgA and IgG IFU, SW4.1_v1 | MVM,MST | Autoantibodies, endomysial(tissue transglutaminase),Antibodies, gliadin | 2 | BioPlex 2200 |
4 | 00847865013000 | SW4.1V1 | 6652365A | Manual & CDs, Celiac IgA and IgG IFU, SW4.1_v1 | MVM,MST | Autoantibodies, endomysial(tissue transglutaminase),Antibodies, gliadin | 2 | BioPlex 2200 |
5 | 00847865012997 | SW4.1_1 | 6652165B | Manual & CDs, APLS IgA IFU, SW4.1_v1, US Only | MID,MSV | SYSTEM, TEST, ANTICARDIOLIPIN IMMUNOLOGICAL,System,test,antibodies,b2 - glycopro SYSTEM, TEST, ANTICARDIOLIPIN IMMUNOLOGICAL,System,test,antibodies,b2 - glycoprotein i (b2 - gpi) | 2 | BioPlex 2200 |
6 | 00847865012980 | SW4.1V1 | 6652065B | Manual & CDs, APLS IgM IFU, SW4.1_v1 | MID,MSV | SYSTEM, TEST, ANTICARDIOLIPIN IMMUNOLOGICAL,System,test,antibodies,b2 - glycopro SYSTEM, TEST, ANTICARDIOLIPIN IMMUNOLOGICAL,System,test,antibodies,b2 - glycoprotein i (b2 - gpi) | 2 | BioPlex 2200 |
7 | 00847865012973 | SW4.1V1 | 6651975B | APLS IgG, IgM and IgA Assay Protocol File CD, SW4.1_v1 US Only | MSV,MID | System,test,antibodies,b2 - glycoprotein i (b2 - gpi),SYSTEM, TEST, ANTICARDIOLI System,test,antibodies,b2 - glycoprotein i (b2 - gpi),SYSTEM, TEST, ANTICARDIOLIPIN IMMUNOLOGICAL | 2 | BioPlex 2200 |
8 | 00847865012966 | SW4.1V1 | 6651965B | Manual & CDs, APLS IgG IFU, SW4.1_v1, US Only | MSV,MID | System,test,antibodies,b2 - glycoprotein i (b2 - gpi),SYSTEM, TEST, ANTICARDIOLI System,test,antibodies,b2 - glycoprotein i (b2 - gpi),SYSTEM, TEST, ANTICARDIOLIPIN IMMUNOLOGICAL | 2 | BioPlex 2200 |
9 | 00847865012614 | SW4.1_V1 | 6651260F | Manual & CDs, EBV IgG IFU, SW4.1v1 | LSE | EPSTEIN-BARR VIRUS, OTHER | 1 | BioPlex 2200 |
10 | 00847865012607 | SW4.1_V1 | 6651270D | EBV IgG Assay Protocol File CD, SW4.1_v1, US | LSE | EPSTEIN-BARR VIRUS, OTHER | 1 | BioPlex 2200 |
11 | 00847865012577 | SW4.1_V1 | 6653860D | Manual & CDs, Rubella & CMV IgM IFU, SW4.1_v1, U.S Only | LFX,LKQ,LFZ | ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA,ANTIBODY IGM,IF, CYTOMEGALOVIRUS VI ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA,ANTIBODY IGM,IF, CYTOMEGALOVIRUS VIRUS,ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS | 2 | BioPlex 2200 |
12 | 00847865012522 | SW4_1 | 6651965A | Manual & CDs, BioPlex 2200 APLS IgG IFU, SW4_v1, US Only | MSV,MID | System,test,antibodies,b2 - glycoprotein i (b2 - gpi),SYSTEM, TEST, ANTICARDIOLI System,test,antibodies,b2 - glycoprotein i (b2 - gpi),SYSTEM, TEST, ANTICARDIOLIPIN IMMUNOLOGICAL | 2 | BioPlex 2200 |
13 | 00847865012515 | SW4_1 | 6652065A | Manual & CDs, APLS IgM IFU, SW4_v1, US Only | MSV,MID | System,test,antibodies,b2 - glycoprotein i (b2 - gpi),SYSTEM, TEST, ANTICARDIOLI System,test,antibodies,b2 - glycoprotein i (b2 - gpi),SYSTEM, TEST, ANTICARDIOLIPIN IMMUNOLOGICAL | 2 | BioPlex 2200 |
14 | 00847865012508 | SW4_1 | 6651975A | APLS IgG, IgM and IgA Assay Protocol File CD, SW4_v1 | MSV,MID | System,test,antibodies,b2 - glycoprotein i (b2 - gpi),SYSTEM, TEST, ANTICARDIOLI System,test,antibodies,b2 - glycoprotein i (b2 - gpi),SYSTEM, TEST, ANTICARDIOLIPIN IMMUNOLOGICAL | 2 | BioPlex 2200 |
15 | 00847865012331 | SW4.1_V2 | 6651170D | ANA Screen with MDSS Assay Protocol File CD, SW4.1_v2 | LLL,LKJ,LJM,MQA,LKO,LRM | EXTRACTABLE ANTINUCLEAR ANTIBODY, ANTIGEN AND CONTROL,ANTINUCLEAR ANTIBODY, ANTI EXTRACTABLE ANTINUCLEAR ANTIBODY, ANTIGEN AND CONTROL,ANTINUCLEAR ANTIBODY, ANTIGEN, CONTROL,ANTINUCLEAR ANTIBODY (ENZYME-LABELED), ANTIGEN, CONTROLS,ANTI-RIBOSOMAL P ANTIBODIES,ANTI-RNP ANTIBODY, ANTIGEN AND CONTROL,ANTI-DNA ANTIBODY (ENZYME-LABELED), ANTIGEN, CONTROL | 2 | BioPlex 2200 |
16 | 00847865011655 | 6653750 | 6653750 | 25-OH Vitamin D Reagent Pack | MRG | SYSTEM, TEST, VITAMIN D | 2 | BioPlex 2200 |
17 | 00847865011648 | 6633740 | 6633740 | 25-OH Vitamin D Control Lot Data | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | BioPlex 2200 |
18 | 00847865011631 | 6633730 | 6633730 | 25-OH Vitamin D Control Set | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | BioPlex 2200 |
19 | 00847865011624 | 6633720 | 6633720 | 25-OH Vitamin D Lot Data | JIT | CALIBRATOR, SECONDARY | 2 | BioPlex 2200 |
20 | 00847865011617 | 6633700 | 6633700 | 25-OH Vitamin D Calibrator Set | JIT | CALIBRATOR, SECONDARY | 2 | BioPlex 2200 |
21 | 00847865011358 | SW4V2 | 6651360F | Manual & CDs, EBV IgM IFU, SW4_v2 | LJN,KTN | ANTIBODY IGM, IF, EPSTEIN-BARR VIRUS,SYSTEM, TEST, INFECTIOUS MONONUCLEOSIS | 1 | BioPlex 2200 |
22 | 00847865011341 | 6651360G | 6651360G | Manual & CDs, EBV IgM IFU, SW4.1_v1 | LJN,KTN | ANTIBODY IGM, IF, EPSTEIN-BARR VIRUS,SYSTEM, TEST, INFECTIOUS MONONUCLEOSIS | 1 | BioPlex 2200 |
23 | 00847865011129 | SW4_1 | 6652360A | Manual & CDs, Celiac IgA and IgG IFU, SW4_v1 | MST,MVM | Antibodies, gliadin,Autoantibodies, endomysial(tissue transglutaminase) | 2 | BioPlex 2200 |
24 | 00847865011105 | 6600306 | 6600306 | BioPlex® 2200 Manual Reagent Pack Piercer | MZF | Test, Hiv Detection | 2 | BioPlex® 2200 |
25 | 00847865011082 | SW4.1V1 | 6651860H | Manual & CDs, Vasculitis IFU, SW4.1_v1 | MOB,MVJ | TEST SYSTEM, ANTINEUTROPHIL CYTOPLASMIC ANTIBODIES (ANCA),Devices, measure, anti TEST SYSTEM, ANTINEUTROPHIL CYTOPLASMIC ANTIBODIES (ANCA),Devices, measure, antibodies to glomerular basement membrane (gbm) | 2 | BioPlex 2200 |
26 | 00847865011075 | SW4.1_1 | 6651665E | U.S. IFU, Manual & CDs, ToRC IgG IFU, SW4.1_v1 | OMI | Multiplex flow immunoassay, t.Gondii, rubella and cmv. | 2 | BioPlex 2200 |
27 | 00847865011006 | SW4.1_V1 | 6653870D | Rubella & CMV IgM Assay Protocol File CD, SW4.1_v1 | LFX,LKQ,LFZ | ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA,ANTIBODY IGM,IF, CYTOMEGALOVIRUS VI ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA,ANTIBODY IGM,IF, CYTOMEGALOVIRUS VIRUS,ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS | 2 | BioPlex 2200 |
28 | 00847865010993 | SW4.1_V2 | 6653370E | HSV-1 & HSV-2 Assay Protocol File CD, SW4.1_v2 | MYF,MXJ | Enzyme linked immunosorbent assay, herpes simplex virus, hsv-2,Enzyme linked imm Enzyme linked immunosorbent assay, herpes simplex virus, hsv-2,Enzyme linked immunosorbent assay, herpes simplex virus, hsv-1 | 2 | BioPlex 2200 |
29 | 00847865010986 | SW4.1_V1 | 6653270E | BioPlex 2200 Anti-CCP Assay Protocol File CD, SW4.1_v1 | JIX,NHX,JJY | CALIBRATOR, MULTI-ANALYTE MIXTURE,ANTIBODIES, ANTI-CYCLIC CITRULLINATED PEPTIDE CALIBRATOR, MULTI-ANALYTE MIXTURE,ANTIBODIES, ANTI-CYCLIC CITRULLINATED PEPTIDE (CCP),Multi-analyte controls, all kinds (assayed) | 1 | BioPlex 2200 |
30 | 00847865010979 | SW4.1_V1 | 6652470D | MMRV IgG Assay Protocol File CD, SW4.1_v1 | LJY,LFY,OPL,LJB | ENZYME LINKED IMMUNOABSORBENT ASSAY, MUMPS VIRUS,ENZYME LINKED IMMUNOABSORBENT A ENZYME LINKED IMMUNOABSORBENT ASSAY, MUMPS VIRUS,ENZYME LINKED IMMUNOABSORBENT ASSAY, VARICELLA-ZOSTER,Multiplex immunoassay for measles virus, mumps virus, rubella and varicella zoster virus,Enzyme linked immunoabsorbent assay, rubeola IgG | 1 | BioPlex 2200 |
31 | 00847865010962 | SW4.1v1 | 6652270B | Celiac IgG Assay Protocol File CD, SW4.1_v1 | MST,MVM | Antibodies, gliadin,Autoantibodies, endomysial(tissue transglutaminase) | 2 | BioPlex 2200 |
32 | 00847865010955 | SW4.1 V1 | 6651870E | Vasculitis Assay Protocol File CD, SW4.1_v1 | MOB,MVJ | TEST SYSTEM, ANTINEUTROPHIL CYTOPLASMIC ANTIBODIES (ANCA),Devices, measure, anti TEST SYSTEM, ANTINEUTROPHIL CYTOPLASMIC ANTIBODIES (ANCA),Devices, measure, antibodies to glomerular basement membrane (gbm) | 2 | BioPlex 2200 |
33 | 00847865010948 | SW4.1_V1 | 6651670H | ToRC IgG Assay Protocol File CD, SW4.1_v1 | OMI | Multiplex flow immunoassay, t.Gondii, rubella and cmv. | 2 | BioPlex 2200 |
34 | 00847865010924 | SW4.1_v1 | 6651470E | Syphilis IgG Assay Protocol File CD, SW4.1_v1 | LIP | ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM | 2 | BioPlex 2200 |
35 | 00847865010917 | 6632220 | 6632220 | Celiac IgG Calibrator Lot Data | JIX | CALIBRATOR, MULTI-ANALYTE MIXTURE | 2 | BioPlex 2200 |
36 | 00847865010900 | 6632320 | 6632320 | Celiac IgA Calibrator Lot Data | JIX | CALIBRATOR, MULTI-ANALYTE MIXTURE | 2 | BioPlex 2200 |
37 | 00847865010894 | 6632240 | 6632240 | Celiac IgG Control Lot Data | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | BioPlex 2200 |
38 | 00847865010887 | 6632340 | 6632340 | Celiac IgA Control Lot Data | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | BioPlex 2200 |
39 | 00847865010863 | 6652250 | 6652250 | Celiac IgG Reagent Pack | MVM,MST | Autoantibodies, endomysial(tissue transglutaminase),Antibodies, gliadin | 2 | BioPlex 2200 |
40 | 00847865010856 | 6652350 | 6652350 | Celiac IgA Reagent Pack | MVM,MST | Autoantibodies, endomysial(tissue transglutaminase),Antibodies, gliadin | 2 | BioPlex 2200 |
41 | 00847865010627 | 6632230 | 6632230 | Celiac IgG Control Set | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | BioPlex 2200 |
42 | 00847865010610 | 6632330 | 6632330 | Celiac IgA Control Set | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | BioPlex 2200 |
43 | 00847865010603 | 6632200 | 6632200 | Celiac IgG Calibrator Set, | JIX | CALIBRATOR, MULTI-ANALYTE MIXTURE | 2 | BioPlex 2200 |
44 | 00847865010597 | 6632300 | 6632300 | Celiac IgA Calibrator Set | JIX | CALIBRATOR, MULTI-ANALYTE MIXTURE | 2 | BioPlex 2200 |
45 | 00847865010580 | SW4_v1 | 6652370A | Celiac IgA Assay Protocol File CD, SW4_v1 | MVM,MST | Autoantibodies, endomysial(tissue transglutaminase),Antibodies, gliadin | 2 | BioPlex 2200 |
46 | 00847865010573 | SW4_v1 | 6652270A | Celiac IgG Assay Protocol file CD, SW4_v1 | MVM,MST | Autoantibodies, endomysial(tissue transglutaminase),Antibodies, gliadin | 2 | BioPlex 2200 |
47 | 00847865006682 | SW4.1_V1 | 6651460F | Manual & CDs, Syphilis IgG IFU, SW4.1_v1 | LIP | ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM | 2 | BioPlex 2200 |
48 | 00847865004725 | SW4_V2 | 6653360E | Manual & CDs, HSV-1 & HSV-2 IgG IFU, SW4_v2 | MXJ,MYF | Enzyme linked immunosorbent assay, herpes simplex virus, hsv-1,Enzyme linked imm Enzyme linked immunosorbent assay, herpes simplex virus, hsv-1,Enzyme linked immunosorbent assay, herpes simplex virus, hsv-2 | 2 | BioPlex 2200 |
49 | 00847865003186 | SW4_ V3 | 6653870C | Rubella & CMV Assay Protocol File CD, SW4_v3 | LFZ,LKQ,LFX | ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS,ANTIBODY IGM,IF, CYTOMEGALO ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS,ANTIBODY IGM,IF, CYTOMEGALOVIRUS VIRUS,ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA | 2 | BioPlex 2200 |
50 | 00847865003179 | SW4_V3 | 6653860C | Manual & CDs, Rubella & CMV IgM IFU, SW4_v3, US Only | LKQ,LFX,LFZ | ANTIBODY IGM,IF, CYTOMEGALOVIRUS VIRUS,ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBE ANTIBODY IGM,IF, CYTOMEGALOVIRUS VIRUS,ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA,ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS | 2 | BioPlex 2200 |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 10304040080594 | 5701036 | 5701036 | Handheld portable analyzer for Lipid and Glucose Testing, Blood Sample used is 40ul | Henry Schein | HENRY SCHEIN, INC. |
2 | 08426950907220 | 701351 | 1. QUANTA Flash Calprotectin Calibrator 1: Two (2) barcode labeled tubes contain 1. QUANTA Flash Calprotectin Calibrator 1: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain recombinant calprotectin with stabilizers and preservatives. 2. QUANTA Flash Calprotectin Calibrator 2: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain recombinant calprotectin with stabilizers and preservatives. 3. QUANTA Flash Calprotectin Calibrator 3: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain recombinant calprotectin with stabilizers and preservatives. | QUANTA Flash® Calprotectin Calibrators | INOVA DIAGNOSTICS, INC. | |
3 | 08426950845256 | 701341 | 1. QUANTA Flash RF IgM Calibrator 1: Two (2) barcode labeled tubes containing 0. 1. QUANTA Flash RF IgM Calibrator 1: Two (2) barcode labeled tubes containing 0.3mL prediluted, ready to use reagent. Calibrators contain human antibodies to RF IgM in stabilizers and preservatives.2. QUANTA Flash RF IgM Calibrator 2: Two (2) barcode labeled tubes containing 0.3mL prediluted, ready to use reagent. Calibrators contain human antibodies to RF IgM in stabilizers and preservatives. | QUANTA Flash RF IgM Calibrators | INOVA DIAGNOSTICS, INC. | |
4 | 08426950835196 | 701346 | 1. QUANTA Flash RF IgA Calibrator 1: Two (2) barcode labeled tubes containing 0. 1. QUANTA Flash RF IgA Calibrator 1: Two (2) barcode labeled tubes containing 0.3mL prediluted, ready to use reagent. Calibrators contain human antibodies to RF IgA in stabilizers and preservatives.2. QUANTA Flash RF IgA Calibrator 2: Two (2) barcode labeled tubes containing 0.3mL prediluted, ready to use reagent. Calibrators contain human antibodies to RF IgA in stabilizers and preservatives. | QUANTA Flash RF IgA Calibrators | INOVA DIAGNOSTICS, INC. | |
5 | 08426950793168 | 701331 | 1. QUANTA Flash HMGCR Calibrator 1: Two (2) barcode labeled tubes containing 0.3 1. QUANTA Flash HMGCR Calibrator 1: Two (2) barcode labeled tubes containing 0.3mL prediluted, ready to use reagent. Calibrators contain human antibodies to HMGCR in stabilizers and preservatives.2. QUANTA Flash HMGCR Calibrator 2: Two (2) barcode labeled tubes containing 0.3mL prediluted, ready to use reagent. Calibrators contain human antibodies to HMGCR in stabilizers and preservatives. | QUANTA Flash® HMGCR Calibrators | INOVA DIAGNOSTICS, INC. | |
6 | 08426950766988 | 701296 | 1. QUANTA Flash LKM-1 Calibrator 1: Two (2) barcode labeled tubes containing 0.3 1. QUANTA Flash LKM-1 Calibrator 1: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies to LKM-1 in stabilizers and preservatives.2. QUANTA Flash LKM-1 Calibrator 2: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies to LKM-1 in stabilizers and preservatives.3. QUANTA Flash LKM-1 Calibrator 3: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies to LKM-1 in stabilizers and preservatives. | QUANTA Flash® Lkm-1 Calibrators | INOVA DIAGNOSTICS, INC. | |
7 | 08426950729938 | 701301 | 1. QUANTA Flash M2 (MIT3) Calibrator 1: Two (2) barcode labeled tubes containing 1. QUANTA Flash M2 (MIT3) Calibrator 1: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies to M2 (MIT3) in stabilizers and preservatives.2. QUANTA Flash M2 (MIT3) Calibrator 2: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies to M2 (MIT3) in stabilizers and preservatives.3. QUANTA Flash M2 (MIT3) Calibrator 3: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies to M2 (MIT3) in stabilizers and preservatives. | QUANTA Flash® M2 (MIT3) Calibrators | INOVA DIAGNOSTICS, INC. | |
8 | 08426950724490 | 701326 | 1. QUANTA Flash Scl-70 Calibrator 1: Two (2) barcode labeled tubes containing 0 1. QUANTA Flash Scl-70 Calibrator 1: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies to Scl-70 in stabilizers and preservatives. 2. QUANTA Flash Scl-70 Calibrator 2: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies to Scl-70 in stabilizers and preservatives. | QUANTA Flash® Scl-70 Calibrators | INOVA DIAGNOSTICS, INC. | |
9 | 08426950622185 | 701126 | 1. QUANTA Flash CCP3 Calibrator 1: Two (2) barcode labeled tubes containing 0.7 1. QUANTA Flash CCP3 Calibrator 1: Two (2) barcode labeled tubes containing 0.7 mL prediluted, ready to use reagent. Calibrators contain human antibodies to CCP3 in stabilizers and preservatives. 2. QUANTA Flash CCP3 Calibrator 2: Two (2) barcode labeled tubes containing 0.7 mL prediluted, ready to use reagent. Calibrators contain human antibodies to CCP3 in stabilizers and preservatives. | QUANTA Flash® CCP3 Calibrators | INOVA DIAGNOSTICS, INC. | |
10 | 08426950601913 | 701176 | 1. QUANTA Flash dsDNA Calibrator 1: Two (2) barcode labeled tubes containing 0.7 1. QUANTA Flash dsDNA Calibrator 1: Two (2) barcode labeled tubes containing 0.7 mL prediluted, ready to use reagent. Calibrators contain human antibodies to dsDNA in stabilizers and preservatives. 2. QUANTA Flash dsDNA Calibrator 2: Two (2) barcode labeled tubes containing 0.7 mL prediluted, ready to use reagent. Calibrators contain human antibodies to dsDNA in stabilizers and preservatives. | QUANTA Flash® dsDNA Calibrators | INOVA DIAGNOSTICS, INC. | |
11 | 08426950597049 | 701146 | 1. QUANTA Flash Ro60 Calibrator 1: Two (2) barcode labeled tubes containing 0.3 1. QUANTA Flash Ro60 Calibrator 1: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies to Ro60 in stabilizers and preservatives. 2. QUANTA Flash Ro60 Calibrator 2: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies to Ro60 in stabilizers and preservatives. | QUANTA Flash® Ro60 Calibrators | INOVA DIAGNOSTICS, INC. | |
12 | 08426950596653 | 701261 | 1. QUANTA Flash Ro52 Calibrator 1: Two (2) barcode labeled tubes containing 0.3 1. QUANTA Flash Ro52 Calibrator 1: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies to Ro52 in stabilizers and preservatives. 2. QUANTA Flash Ro52 Calibrator 2: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies to Ro52 in stabilizers and preservatives. | QUANTA Flash® Ro52 Calibrators | INOVA DIAGNOSTICS, INC. | |
13 | 08426950596264 | 701151 | 1. QUANTA Flash SS-B Calibrator 1: Two (2) barcode labeled tubes containing 0.3 1. QUANTA Flash SS-B Calibrator 1: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies to SS-B in stabilizers and preservatives. 2. QUANTA Flash SS-B Calibrator 2: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies to SS-B in stabilizers and preservatives. | QUANTA Flash® SS-B Calibrators | INOVA DIAGNOSTICS, INC. | |
14 | 08426950596028 | 701121 | 1. QUANTA Flash Sm Calibrator 1: Two (2) barcode labeled tubes containing 0.3 mL 1. QUANTA Flash Sm Calibrator 1: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies to Sm in stabilizers and preservatives. 2. QUANTA Flash Sm Calibrator 2: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies to Sm in stabilizers and preservatives. | QUANTA Flash® Sm Calibrators | INOVA DIAGNOSTICS, INC. | |
15 | 08426950595724 | 701161 | 1. QUANTA Flash Jo-1 Calibrator 1: Two (2) barcode labeled tubes containing 0.3 1. QUANTA Flash Jo-1 Calibrator 1: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies to Jo-1 in buffer, stabilizers, and preservatives.2. QUANTA Flash Jo-1 Calibrator 2: Two (2) barcode labeled tubes containing 0.3 mL, prediluted, ready to use reagent. Calibrators contain human antibodies to Jo-1 in buffer, stabilizers, and preservatives. | QUANTA Flash® Jo-1 Calibrators | INOVA DIAGNOSTICS, INC. | |
16 | 08426950595717 | 701116 | 1. QUANTA Flash RNP Calibrator 1: Two (2) barcode labeled tubes containing 0.3 m 1. QUANTA Flash RNP Calibrator 1: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies to RNP in stabilizers and preservatives. 2. QUANTA Flash RNP Calibrator 2: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies to RNP in stabilizers and preservatives. | QUANTA Flash® RNP Calibrators | INOVA DIAGNOSTICS, INC. | |
17 | 08058056682291 | 04Y85-01 | 04Y85-01 | Lipase NG OC Cal must be used only for the calibration of Lipase NG. For In Vitr Lipase NG OC Cal must be used only for the calibration of Lipase NG. For In Vitro Diagnostic use. | Lipase NG OC Cal | SENTINEL CH. SPA |
18 | 08058056681768 | 1665001 | 1665001 | ACE Calibrator is intended to be used with Sentinel ACE Liquid Reagent for the p ACE Calibrator is intended to be used with Sentinel ACE Liquid Reagent for the preparation of the calibration for the kinetic determination of angiotensin converting enzyme (ACE) assay in human serum or plasma. For In Vitro Diagnostic use. | ACE Calibrator | SENTINEL CH. SPA |
19 | 07613336191552 | 09315314190 | 09315314190 | proBNP G2 CS Elecsys E2G V2.1 | Elecsys proBNP II CalSet | ROCHE DIAGNOSTICS GMBH |
20 | 07613336191545 | 09315306190 | 09315306190 | proBNP STAT CS Elecsys V2.1 | Elecsys proBNP II STAT CalSet | ROCHE DIAGNOSTICS GMBH |
21 | 07613336191538 | 09315292190 | 09315292190 | proBNP G2 CS Elecsys V2.1 | Elecsys proBNP II CalSet | ROCHE DIAGNOSTICS GMBH |
22 | 07613336172667 | 09038116190 | 09038116190 | Vitamin D total G3 CS Elecsys | CalSet Vitamin D total III | ROCHE DIAGNOSTICS GMBH |
23 | 07613336171776 | 09013326190 | 09013326190 | AMH CalSet | ROCHE DIAGNOSTICS GMBH | |
24 | 07613336170397 | 08932417190 | 08932417190 | FSH CalSet II | ROCHE DIAGNOSTICS GMBH | |
25 | 07613336169315 | 07679866190 | 07679866190 | CalSet Androstenedione | ROCHE DIAGNOSTICS GMBH | |
26 | 07613336160336 | 08496641190 | 08496641190 | CalSet Anti-TSHR | ROCHE DIAGNOSTICS GMBH | |
27 | 07613336157824 | 08445699190 | 08445699190 | Tina-quant Hemoglobin A1cDx Gen.3 | ROCHE DIAGNOSTICS GMBH | |
28 | 07613336157664 | 08443459160 | 08443459160 | TSH CalSet | ROCHE DIAGNOSTICS GMBH | |
29 | 07613336148280 | 08250499160 | 08250499160 | CalSet Troponin T Gen 5 | ROCHE DIAGNOSTICS GMBH | |
30 | 07613336147696 | 08243930190 | 08243930190 | CalSet PTH STAT | ROCHE DIAGNOSTICS GMBH | |
31 | 07613336147689 | 08243891190 | 08243891190 | CalSet II PTH | ROCHE DIAGNOSTICS GMBH | |
32 | 07613336147672 | 08243875190 | 08243875190 | CalSet PTH | ROCHE DIAGNOSTICS GMBH | |
33 | 07613336143148 | 07475969190 | 07475969190 | CalSet IGF-1 | ROCHE DIAGNOSTICS GMBH | |
34 | 07613336142707 | 07574762190 | 07574762190 | CalSet IGFBP-3 | ROCHE DIAGNOSTICS GMBH | |
35 | 07613336140680 | 08105677190 | 08105677190 | Fructosamine | ROCHE DIAGNOSTICS GMBH | |
36 | 07613336120927 | 08056668190 | 08056668190 | Tina-quant Hemoglobin A1cDx Gen.3 | ROCHE DIAGNOSTICS GMBH | |
37 | 07070060005683 | 1115015 | 1115015 | Hemoglobin A1c test kit. Intended use: For determination of hemoglobin A1c in hu Hemoglobin A1c test kit. Intended use: For determination of hemoglobin A1c in human whole blood. Contents: 15 Test Cartridges. 1 Package Insert. DI covers Alere Afinion HbA1c and Afinion HbA1c. | Alere Afinion™ HbA1c | ABBOTT DIAGNOSTICS TECHNOLOGIES AS |
38 | 06944904084985 | 105-011385-00 | Urine Standard (Indirect)(FDA) | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. | ||
39 | 06944904084978 | 105-011384-00 | Serum Standard (Indirect)(FDA) | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. | ||
40 | 05700572014294 | X0974 | Cystatin C Calibrator | Dako | AGILENT TECHNOLOGIES SINGAPORE PTE LTD | |
41 | 05700572014287 | X0973 | Cystatin C Control Set | Cystatin C Control Set | AGILENT TECHNOLOGIES SINGAPORE PTE LTD | |
42 | 05700572013853 | LX002 | Cystatin C Immunoparticles | Dako | AGILENT TECHNOLOGIES SINGAPORE PTE LTD | |
43 | 05391516749473 | Tri-stat 2 Analyzer | 03-06-0002 | Tri-stat 2 Analyzer | Trinity Biotech | PRIMUS CORPORATION |
44 | 05391516748636 | PDQ Wash Reagent | 01-03-0067 | Hemoglobin A1c assay, PDQ Wash Reagent | Trinity Biotech | PRIMUS CORPORATION |
45 | 05391516748629 | PDQ Diluent Reagent - 940mL | 01-03-0066 | Hemoglobin A1c assay, PDQ Diluent Reagent - 940mL | Trinity Biotech | PRIMUS CORPORATION |
46 | 05391516748612 | PDQ 2 Reagent - 940mL | 01-03-0065 | Hemoglobin A1c assay, PDQ 2 Reagent - 940mL | Trinity Biotech | PRIMUS CORPORATION |
47 | 05391516748605 | PDQ1 Reagent - 940mL | 01-03-0064 | Hemoglobin A1c assay, PDQ1 Reagent - 940mL | Trinity Biotech | PRIMUS CORPORATION |
48 | 05391516748223 | Tri-stat Reagent Kit | 03-06-0010 | Hemoglobin A1c assay, Tri-stat Reagent Kit | Trinity Biotech | PRIMUS CORPORATION |
49 | 05391516748162 | Ultra2 Affinity A1c 3000 | 01-04-0080 | Hemoglobin A1c assay, Ultra2 Affinity A1c 3000 | Trinity Biotech | PRIMUS CORPORATION |
50 | 05391516748155 | Ultra2 Affinity HbA1c Analyzer (110V) | 03-01-0052 | Hemoglobin A1c assay, Ultra2 Affinity HbA1c Analyzer (110V) | Trinity Biotech | PRIMUS CORPORATION |