| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00868665000045 | AC-NFC Meter | 3K-01-16003K | Rosie SmartMeter NFC Professional Blood Glucose Meter | NBW | System, Test, Blood Glucose, Over The Counter | Rosie SmartMeter NFC Professional | |
| 2 | 00857596008008 | AC-11 AC302 | 3K-01-16003N | GL GoodLife AC-302 Blood Meter(No GCS), Economy type | NBW,LFR | System, Test, Blood Glucose, Over The Counter,Glucose Dehydrogenase, Glucose | GL GoodLife AC-302 Blood Glucose Monitoring System, Economy type(CORP.) | |
| 3 | 00850009854032 | 3K-01-250034 | 3K-01-250034 | metene Enhance P5 Blood Glucose Monitoring System | NBW | System, Test, Blood Glucose, Over The Counter | metene Enhance Blood Glucose Monitoring System | |
| 4 | 00389154000389 | AC11 | 3K-01-16003H | Rosie SmartMeter Blood Glucose Monitoring System | LFR,JJX,NBW | Glucose Dehydrogenase, Glucose,Single (Specified) Analyte Controls (Assayed And Glucose Dehydrogenase, Glucose,Single (Specified) Analyte Controls (Assayed And Unassayed),System, Test, Blood Glucose, Over The Counter | Rosie SmartMeter | |
| 5 | 00389154000266 | IG STRIP FOIL | 3L-10-810037 | GL GoodLife Blood Glucose Test Strip-Foil For Cloudia | JJX,LFR,NBW | Single (Specified) Analyte Controls (Assayed And Unassayed),Glucose Dehydrogenas Single (Specified) Analyte Controls (Assayed And Unassayed),Glucose Dehydrogenase, Glucose,System, Test, Blood Glucose, Over The Counter | 1 | GL GoodLife Blood Glucose Test Strip-Foil For Cloudia |
| 6 | 04711200722864 | GL vial | GlucoLeader Enhance GL Blood Glucose Test Strip | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | GlucoLeader Enhance Blood Glucose Test Strip | |
| 7 | 04711200722246 | 3K-01-140108 | 3K-01-140108 | GlucoLeader Enhance P5 Blood Glucose Monitoring System (BR/IQ) | NBW | System, Test, Blood Glucose, Over The Counter | GlucoLeader Enhance Blood Glucose Monitoring System(BR/IQ) | |
| 8 | 04711200720068 | 3S-01-22X034 | 3S-01-22X034 | GlucoLeader Enhance GL Blood Glucose Test Strip | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | GlucoLeader Enhance Blood Glucose Test Strip | |
| 9 | 04260236850619 | 3K-01-16003A | 3K-01-16003A | PRECICHEK AutoCode AC302 Blood Glucose Monitoring System. | JJX,LFR,NBW | Single (Specified) Analyte Controls (Assayed And Unassayed),Glucose Dehydrogenas Single (Specified) Analyte Controls (Assayed And Unassayed),Glucose Dehydrogenase, Glucose,System, Test, Blood Glucose, Over The Counter | 1 | PRECICHEK AutoCode AC302 |
| 10 | 00868665000052 | AC-11 Pro-Strip | 3L-10-16003E | Rosie SmartMeter Professional Strip-Foil | NBW | System, Test, Blood Glucose, Over The Counter | 2 | Rosie SmartMeter Professional Strip |
| 11 | 00857596008046 | AC-11 AC302 (vial) | 3S-01-16003E | GL GoodLife Blood Glucose Test Strip(AC-302) | NBW,LFR | System, Test, Blood Glucose, Over The Counter,Glucose Dehydrogenase, Glucose | 2 | GL GoodLife Blood Glucose Test Strip(CORP.) |
| 12 | 00857596008022 | AC-11 AC302 | 3K-01-16003R | GL GoodLife AC-302 Blood Glucose Meter (include GCS ),Standard type. | 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 | GL GoodLife AC-302 Blood Glucose Monitoring System(CORP.) | |
| 13 | 00389154000594 | AC-11 AC302 (vial) | 3S-01-16003E | GL GoodLife Blood Glucose Test Strip(AC-302) | LFR,NBW | Glucose Dehydrogenase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | GL GoodLife Blood Glucose Test Strip |
| 14 | 00389154000570 | AC-11 vial | 3S-01-16003C | GL GoodLife AC300 Blood Glucose Test Strip | LFR,JJX,NBW | Glucose Dehydrogenase, Glucose,Single (Specified) Analyte Controls (Assayed And Glucose Dehydrogenase, Glucose,Single (Specified) Analyte Controls (Assayed And Unassayed),System, Test, Blood Glucose, Over The Counter | 1 | GL GoodLife AC300 Test Strip-Vial |
| 15 | 00389154000501 | AC11-NFC | delete | Rosie SmartMeter NFC Professional Blood Glucose Monitoring System (Rosie SmartMe Rosie SmartMeter NFC Professional Blood Glucose Monitoring System (Rosie SmartMeter NFC Professional) | LFR,NBW | Glucose Dehydrogenase, Glucose,System, Test, Blood Glucose, Over The Counter | Rosie SmartMeter | |
| 16 | 00389154000204 | 3L-10-16003A | 3L-10-16003A | GL GoodLife Blood Glucose Test Strip(Foil) | LFR,JJX,NBW | Glucose Dehydrogenase, Glucose,Single (Specified) Analyte Controls (Assayed And Glucose Dehydrogenase, Glucose,Single (Specified) Analyte Controls (Assayed And Unassayed),System, Test, Blood Glucose, Over The Counter | 1 | GL GoodLife Blood Glucose Test Strip AC (50 Strips&lancets in foil) |
| 17 | 04711200722444 | 3S-01-14010B | 3S-01-14010B | GlucoLeader Enhance Blood Glucose C4H vial packed test strip(BR/VM) | NBW | System, Test, Blood Glucose, Over The Counter | GlucoLeader Enhance Blood Glucose Test Strip(BR/VM) | |
| 18 | 04711200721249 | 3S-01-1400333 | 3S-01-1400333 | GlucoLeader Enhance GL Blood Glucose Test Strip(for AF-SSA) | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | GlucoLeader Enhance Blood Glucose Test Strip(for AF-SSA) | |
| 19 | 04711200720617 | 3K-01-140036 | 3K-01-140036 | GlucoLeader Enhance GEBH Blood Glucose Monitoring System | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | GlucoLeader Enhance Blood Glucose Monitoring System |
| 20 | 04711200720570 | 3K-01-140039 | 3K-01-140039 | GlucoLeader Enhance GEBH Blood Glucose Monitoring System. | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | GlucoLeader Enhance Blood Glucose Monitoring System | |
| 21 | 04260236850411 | 3S-01-160032 | 3S-01-160032 | PRECICHEK AutoCode Blood Glucose ACH vial packed test strip | 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 | PRECICHEK AutoCode vial packed test Strip | |
| 22 | 04260236850367 | 3L-10-140033 | 3L-10-140033 | FIA Salut Blood Glucose KPH foil packed test strip | LFR,NBW | Glucose Dehydrogenase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | FIA Salut foil packed test strip |
| 23 | 00868665000069 | 3C-01-160033 | 3C-01-160033 | Rosie SmartMeter glucose control solution | JJX,NBW,LFR | Single (Specified) Analyte Controls (Assayed And Unassayed),System, Test, Blood Single (Specified) Analyte Controls (Assayed And Unassayed),System, Test, Blood Glucose, Over The Counter,Glucose Dehydrogenase, Glucose | Rosie SmartMeter Glucose Control Solutions | |
| 24 | 00389154000631 | AC-11 AC302 | 3K-01-16003R | GL GoodLife AC-302 Blood Glucose Meter (include GCS ),Standard type. | LFR,JJX,NBW | Glucose Dehydrogenase, Glucose,Single (Specified) Analyte Controls (Assayed And Glucose Dehydrogenase, Glucose,Single (Specified) Analyte Controls (Assayed And Unassayed),System, Test, Blood Glucose, Over The Counter | GL GoodLife AC-302 Blood Glucose Monitoring System | |
| 25 | 00389154000198 | AC11 | 3K-01-16003C | GL GoodLife AC-300 Blood Glucose Monitoring System | LFR,NBW | Glucose Dehydrogenase, Glucose,System, Test, Blood Glucose, Over The Counter | GL GoodLife | |
| 26 | 04711200722451 | 3K-01-14010B | 3K-01-14010B | GlucoseLeader Enhance P5 Blood Glucose Monitoring System(BR/VM) | NBW | System, Test, Blood Glucose, Over The Counter | GlucoseLeader Enhance Blood Glucose Monitoring System(BR/VM) | |
| 27 | 04711200721850 | AC11-NFC | 3K-01-16003G | The GoodLife AC-300 Professional Blood Glucose Monitoring System.(No NFC) | LFR,NBW | Glucose Dehydrogenase, Glucose,System, Test, Blood Glucose, Over The Counter | GL GoodLife | |
| 28 | 04711200721034 | 3L-10-160032 | 3L-10-160032 | GoodLife Blood Glucose ACH foil packed test strip. | 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) | GoodLife foil packed test strip | |
| 29 | 00389154000372 | IG01 | 3K-01-810037 | GL GoodLife Blood Glucose Monitoring System(Cloudia) | LFR,JJX,NBW | Glucose Dehydrogenase, Glucose,Single (Specified) Analyte Controls (Assayed And Glucose Dehydrogenase, Glucose,Single (Specified) Analyte Controls (Assayed And Unassayed),System, Test, Blood Glucose, Over The Counter | GL GoodLife | |
| 30 | 04711200722284 | 3K-01-14010C | 3K-01-14010C | GlucoLeader Enhance P5 Blood Glucose Monitoring System (BR/BMT) | NBW | System, Test, Blood Glucose, Over The Counter | GlucoLeader Enhance Blood Glucose Monitoring System(BR/BMT) | |
| 31 | 04711200721898 | 3L-10-120032 | 3L-10-120032 | GlucoLeader Enhance GL Blood Glucose Test Strip(for PTA) | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | GlucoLeader Enhance Blood Glucose Test Strip(for PTA) | |
| 32 | 04711200721843 | 3L-10-14003T | 3L-10-14003T | GlucoLeader Enhance GL Blood Glucose foil packed test strip | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | GlucoLeader Enhance Blood Glucose foil packed test strip | |
| 33 | 00389154000693 | 3L-10-16003F | 3L-10-16003F | GL GoodLife Blood Glucose Test Strip(Content:50 strips and 50 lancet.) | 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) | 1 | GL GoodLife AC11-Strip(foil) |
| 34 | 00389154000679 | 3K-01-16003S | 3K-01-16003S | GL GoodLife Blood Glucose Meter (single patient home use) | LFR,JJX | Glucose Dehydrogenase, Glucose,Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | GL GoodLife Blood Glucose Meter AC-11 |
| 35 | 00389154000549 | 3C-01-160032 | 3C-01-160032 | GL GoodLife Glucose Control Solution | JJX,LFR,NBW | Single (Specified) Analyte Controls (Assayed And Unassayed),Glucose Dehydrogenas Single (Specified) Analyte Controls (Assayed And Unassayed),Glucose Dehydrogenase, Glucose,System, Test, Blood Glucose, Over The Counter | GL GoodLife Glucose Control Solutions | |
| 36 | 04260236851159 | 3S-01-160037 | 3S-01-160037 | PRECICHEK AutoCode Blood Glucose ACH vial packed test strip. | JJX,LFR,NBW | Single (Specified) Analyte Controls (Assayed And Unassayed),Glucose Dehydrogenas Single (Specified) Analyte Controls (Assayed And Unassayed),Glucose Dehydrogenase, Glucose,System, Test, Blood Glucose, Over The Counter | 1 | PRECICHEK AutoCode vial packed test strip |
| 37 | 04260236850916 | 3S-01-16003F | 3S-01-16003F | PRECICHEK AutoCode Blood Glucose ACH vial packed test strip. | JJX,LFR,NBW | Single (Specified) Analyte Controls (Assayed And Unassayed),Glucose Dehydrogenas Single (Specified) Analyte Controls (Assayed And Unassayed),Glucose Dehydrogenase, Glucose,System, Test, Blood Glucose, Over The Counter | 1 | PRECICHEK AutoCode vial packed test strip |
| 38 | 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 | JJX,LFR,NBW | Single (Specified) Analyte Controls (Assayed And Unassayed),Glucose Dehydrogenas Single (Specified) Analyte Controls (Assayed And Unassayed),Glucose Dehydrogenase, Glucose,System, Test, Blood Glucose, Over The Counter | 1 | GL GoodLife Glucose Control Solution(Level 1) |
| 39 | 04711200722895 | 3S-01-1400A3 | Renpho Blood Glucose vial packed test strip | NBW | System, Test, Blood Glucose, Over The Counter | 2 | Renpho Blood Glucose vial packed test strip | |
| 40 | 04711200721720 | 3S-01-14010A | 3S-01-14010A | GlucoLeader Enhance Blood Glucose Test Strip(BR/IQ) | NBW | System, Test, Blood Glucose, Over The Counter | GlucoLeader Enhance Blood Glucose Test Strip(BR/IQ) | |
| 41 | 04260236851142 | 3L-10-16003B | 3L-10-16003B | PRECICHEK AutoCode Blood Glucose ACH foil packed test strip | JJX,LFR,NBW | Single (Specified) Analyte Controls (Assayed And Unassayed),Glucose Dehydrogenas Single (Specified) Analyte Controls (Assayed And Unassayed),Glucose Dehydrogenase, Glucose,System, Test, Blood Glucose, Over The Counter | 1 | PRECICHEK AutoCode foil packed test strip |
| 42 | 04260236851111 | 3L-10-16003H | 3L-10-16003H | PRECICHEK AutoCode Blood Glucose ACH foil packed test strip | 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 | 1 | PRECICHEK AutoCode foil packed test strip |
| 43 | 04260236851067 | 3L-10-16003G | 3L-10-16003G | PRECICHEK AutoCode Blood Glucose ACH foil packed test strip | JJX,LFR,NBW | Single (Specified) Analyte Controls (Assayed And Unassayed),Glucose Dehydrogenas Single (Specified) Analyte Controls (Assayed And Unassayed),Glucose Dehydrogenase, Glucose,System, Test, Blood Glucose, Over The Counter | 1 | PRECICHEK AutoCode foil packed test strip |
| 44 | 04260236851012 | 3S-01-1400A2 | 3S-01-1400A2 | FIA Salut Blood Glucose KPH vial packed test strip | LFR,NBW | Glucose Dehydrogenase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | FIA Salut vial packed test strip |
| 45 | 04260236850848 | 3S-01-140996 | 3S-01-140996 | FIA Salut Blood Glucose KPH vial packed test strip(for Elhenawy) | LFR,NBW | Glucose Dehydrogenase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | FIA Salut vial packed test strip(for Elhenawy) |
| 46 | 04260236850664 | 3L-10-16003D | 3L-10-16003D | PRECICHEK AutoCode Blood Glucose ACH foil packed test strip | JJX,LFR,NBW | Single (Specified) Analyte Controls (Assayed And Unassayed),Glucose Dehydrogenas Single (Specified) Analyte Controls (Assayed And Unassayed),Glucose Dehydrogenase, Glucose,System, Test, Blood Glucose, Over The Counter | 1 | PRECICHEK AutoCode foil packed test strip |
| 47 | 04260236850480 | 3S-01-1400334 | 3S-01-1400334 | FIA Salut Blood Glucose KPH vial packed test strip | LFR,NBW | Glucose Dehydrogenase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | FIA Salut vial packed test strip |
| 48 | 04260236850466 | 3S-01-1400335 | 3S-01-1400335 | FIA Salut Blood Glucose KPH vial packed test strip. | LFR,NBW | Glucose Dehydrogenase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | FIA Salut vial packed test strip |
| 49 | 04260236850459 | 3L-10-14003A | 3L-10-14003A | FIA Salut Blood Glucose KPH foil packed test strip(for SS) | LFR,NBW | Glucose Dehydrogenase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | FIA Salut foil packed test strip(for SS) |
| 50 | 04260236850329 | 3L-10-160031 | 3L-10-160031 | PRECICHEK AutoCode Blood Glucose ACH foil packed test strip | 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 | 1 | PRECICHEK AutoCode foil packed test strip |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 08806128351589 | AGM-513S | metene Blood Glucose Monitoring System | ALL MEDICUS CO.,LTD. | ||
| 2 | 08806128351565 | AGM-513S | metene Blood Glucose Test Meter | ALL MEDICUS CO.,LTD. | ||
| 3 | 08806128351534 | AGM-513S | metene Blood Glucose Test Strip | ALL MEDICUS CO.,LTD. | ||
| 4 | 08806128351503 | AGM-513S | metene Control Solution | ALL MEDICUS CO.,LTD. | ||
| 5 | 08806128340064 | AGM-4000 | Embrace Pro Blood Glucose Test Meter | ALL MEDICUS CO.,LTD. | ||
| 6 | 08806128340064 | AGM-4000 | Embrace Pro Blood Glucose Test Meter | ALL MEDICUS CO.,LTD. | ||
| 7 | 08806128340064 | AGM-4000 | Embrace Pro Blood Glucose Test Meter | ALL MEDICUS CO.,LTD. | ||
| 8 | 08806128340019 | AGM-4000 | Embrace Pro Blood Glucose Test Strip | ALL MEDICUS CO.,LTD. | ||
| 9 | 08806128340019 | AGM-4000 | Embrace Pro Blood Glucose Test Strip | ALL MEDICUS CO.,LTD. | ||
| 10 | 08806128340019 | AGM-4000 | Embrace Pro Blood Glucose Test Strip | ALL MEDICUS CO.,LTD. | ||
| 11 | 08806128340002 | AGM-4000 | Embrace Pro Control Solution | ALL MEDICUS CO.,LTD. | ||
| 12 | 08806128340002 | AGM-4000 | Embrace Pro Control Solution | ALL MEDICUS CO.,LTD. | ||
| 13 | 08806128340002 | AGM-4000 | Embrace Pro Control Solution | ALL MEDICUS CO.,LTD. | ||
| 14 | 08718734961406 | 025.000.005 | GlucoLin is an assayed glucose control intended for professional use in the veri GlucoLin is an assayed glucose control intended for professional use in the verification of the linearity of the HemoCue® Glucose systems.A box of GlucoLin contains 5 levels of control material:GlucoLin XLow: 08718734961352GlucoLin Low: 08718734961369GlucoLin Normal: 08718734961376GlucoLin High: 08718734961383GlucoLin XHigh: 08718734961390 | GlucoLin | EUROTROL B.V. | |
| 15 | 08718734960935 | 180.013.002 | Eurotrol GlucoTrol-AQ is an assayed glucose control intended for professional us Eurotrol GlucoTrol-AQ is an assayed glucose control intended for professional use in the verification of the precision and accuracy of the HemoCue Glucose 201 analyzer.A box of Eurotrol GlucoTrol-AQ contains 2 levels of control material:GlucoTrol-AQ Low (1): 08718734961536GlucoTrol-AQ High (3): 08718734961543 | Eurotrol GlucoTrol-AQ | EUROTROL B.V. | |
| 16 | 08718734960645 | AlbuTrol Level 2 | 189.002.002 | Eurotrol AlbuTrol® is an assayed albumin control intended for professional use i Eurotrol AlbuTrol® is an assayed albumin control intended for professional use in the verification of the precision and accuracy of the HemoCue® Albumin 201 system. Eurotrol AlbuTrol® is intended for the quantitative determination of albumin. | Eurotrol AlbuTrol | EUROTROL B.V. |
| 17 | 08718734960621 | AlbuTrol Level 1 | 189.001.002 | Eurotrol AlbuTrol® is an assayed albumin control intended for professional use i Eurotrol AlbuTrol® is an assayed albumin control intended for professional use in the verification of the precision and accuracy of the HemoCue® Albumin 201 system. Eurotrol AlbuTrol® is intended for the quantitative determination of albumin. | Eurotrol AlbuTrol | EUROTROL B.V. |
| 18 | 08718734960607 | GlucoTrol-NG Level 4 | 170.004.002 | Eurotrol GlucoTrol-NG is an assayed glucose control intended for professional us Eurotrol GlucoTrol-NG is an assayed glucose control intended for professional use in the verification of the precision and accuracy of HemoCue® Glucose systems. | Eurotrol GlucoTrol-NG | EUROTROL B.V. |
| 19 | 08718734960584 | GlucoTrol-NG Level 3 | 170.003.002 | Eurotrol GlucoTrol-NG is an assayed glucose control intended for professional us Eurotrol GlucoTrol-NG is an assayed glucose control intended for professional use in the verification of the precision and accuracy of HemoCue® Glucose systems. | Eurotrol GlucoTrol-NG | EUROTROL B.V. |
| 20 | 08718734960560 | GlucoTrol-NG Level 2 | 170.002.002 | Eurotrol GlucoTrol-NG is an assayed glucose control intended for professional us Eurotrol GlucoTrol-NG is an assayed glucose control intended for professional use in the verification of the precision and accuracy of HemoCue® Glucose systems. | Eurotrol GlucoTrol-NG | EUROTROL B.V. |
| 21 | 08426951301706 | 00009800022 | 00009800022 | 1. HemosIL Acustar ß2GP1-Domain1 Low Control, containing: 3 x 1 mL barcoded tube 1. HemosIL Acustar ß2GP1-Domain1 Low Control, containing: 3 x 1 mL barcoded tubes of a solution with human antibodies to ß2GP1-Domain1 in buffer, stabilizers, and preservatives. 2. HemosIL Acustar ß2GP1-Domain1 High Control, containing: 3 x 1 mL barcoded tubes of a solution with human antibodies to ß2GP1-Domain1 in buffer, stabilizers, and preservatives. | HemosIL AcuStar Anti-B2GPI Domain 1 Controls | INSTRUMENTATION LABORATORY COMPANY |
| 22 | 08426950928782 | 701352 | 1. QUANTA Flash Calprotectin Low Control: Two (2) barcode labeled tubes containi 1. QUANTA Flash Calprotectin Low Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain recombinant calprotectin with stabilizers and preservatives. 2. QUANTA Flash Calprotectin High Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain recombinant calprotectin with stabilizers and preservatives. | QUANTA Flash® Calprotectin Controls | INOVA DIAGNOSTICS, INC. | |
| 23 | 08426950869320 | 701347 | 1. QUANTA Flash RF IgA Negative Control: Two (2) barcode labeled tubes containin 1. QUANTA Flash RF IgA Negative Control: Two (2) barcode labeled tubes containing 0.5mL, ready to use reagent. Controls contain human antibodies to RF IgA in stabilizers and preservatives.2. QUANTA Flash RF IgA Postitive Control: Two (2) barcode labeled tubes containing 0.5mL, ready to use reagent. Controls contain human antibodies to RF IgA in stabilizers and preservatives. | QUANTA Flash RF IgA Controls | INOVA DIAGNOSTICS, INC. | |
| 24 | 08426950845263 | 701342 | 1. QUANTA Flash RF IgM Negative Control: Two (2) barcode labeled tubes containin 1. QUANTA Flash RF IgM Negative Control: Two (2) barcode labeled tubes containing 0.5mL, ready to use reagent. Controls contain human antibodies to RF IgM in stabilizers and preservatives.2. QUANTA Flash RF IgM Positive Control: Two (2) barcode labeled tubes containing 0.5mL, ready to use reagent. Controls contain human antibodies to RF IgM in stabilizers and preservatives. | QUANTA Flash RF IgM Controls | INOVA DIAGNOSTICS, INC. | |
| 25 | 08426950793175 | 701332 | 1. QUANTA Flash HMGCR Negative Control: Two (2) barcode labeled tubes containing 1. QUANTA Flash HMGCR Negative Control: Two (2) barcode labeled tubes containing 0.5mL, ready to use reagent. Controls contain human antibodies to HMGCR in stabilizers and preservatives.2. QUANTA Flash HMGCR Positive Control: Two (2) barcode labeled tubes containing 0.5mL, ready to use reagent. Controls contain human antibodies to HMGCR in stabilizers and preservatives. | QUANTA Flash® HMGCR Controls | INOVA DIAGNOSTICS, INC. | |
| 26 | 08426950766995 | 701297 | 1. QUANTA Flash LKM-1 Negative Control: Two (2) barcode labeled tubes containing 1. QUANTA Flash LKM-1 Negative Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to LKM-1 in stabilizers and preservatives.2. QUANTA Flash LKM-1 Positive Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to LKM-1 in stabilizers, and preservatives." | QUANTA Flash® LKM-1 Controls | INOVA DIAGNOSTICS, INC. | |
| 27 | 08426950730095 | 701302 | 1. QUANTA Flash M2 (MIT3) Negative Control: Two (2) barcode labeled tubes contai 1. QUANTA Flash M2 (MIT3) Negative Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to M2 (MIT3) in stabilizers and preservatives.2. QUANTA Flash M2 (MIT3) Positive Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to M2 (MIT3) in stabilizers, and preservatives. | QUANTA Flash® M2 (MIT3) Controls | INOVA DIAGNOSTICS, INC. | |
| 28 | 08426950724483 | 701327 | 1. QUANTA Flash Scl-70 Negative Control: Two (2) barcode labeled tubes containin 1. QUANTA Flash Scl-70 Negative Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to Scl-70 in stabilizers and preservatives.2. QUANTA Flash Scl-70 Positive Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to Scl-70 in stabilizers, and preservatives. | QUANTA Flash® Scl-70 Controls | INOVA DIAGNOSTICS, INC. | |
| 29 | 08426950622192 | 701127 | 1. QUANTA Flash CCP3 Negative Control: Two (2) barcode labeled tubes containing 1. QUANTA Flash CCP3 Negative Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to CCP3 in stabilizers and preservatives.2. QUANTA Flash CCP3 Positive Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to CCP3 in stabilizers, and preservatives. | QUANTA Flash® CCP3 Controls | INOVA DIAGNOSTICS, INC. | |
| 30 | 08426950601944 | 701187 | 1. QUANTA Flash ß2GP1-Domain1 Low Control, containing: 3 x 1 mL barcoded tubes o 1. QUANTA Flash ß2GP1-Domain1 Low Control, containing: 3 x 1 mL barcoded tubes of a solution with human antibodies to ß2GP1-Domain1 in buffer, stabilizers, and preservatives.2. QUANTA Flash ß2GP1-Domain1 High Control, containing: 3 x 1 mL barcoded tubes of a solution with human antibodies to ß2GP1-Domain1 in buffer, stabilizers, and preservatives. | QUANTA Flash® B2GP1-Domain1 Controls | INOVA DIAGNOSTICS, INC. | |
| 31 | 08426950601920 | 701177 | 1. QUANTA Flash dsDNA Low Control: Two (2) barcode labeled tubes containing 0.7 1. QUANTA Flash dsDNA Low Control: Two (2) barcode labeled tubes containing 0.7 mL, ready to use reagent. Controls contain human antibodies to dsDNA in stabilizers and preservatives.2. QUANTA Flash dsDNA High Control: Two (2) barcode labeled tubes containing 0.7 mL, ready to use reagent. Controls contain human antibodies to dsDNA in stabilizers, and preservatives. | QUANTA Flash® dsDNA Controls | INOVA DIAGNOSTICS, INC. | |
| 32 | 08426950597483 | 701227 | 1. QUANTA Flash aCL IgA Low Control: 3 x 1 mL barcoded tubes of a solution with 1. QUANTA Flash aCL IgA Low Control: 3 x 1 mL barcoded tubes of a solution with aCL IgA in phosphate buffer, containing fetal bovine serum, stabilizers and preservative.2. QUANTA Flash aCL IgA High Control: 3 x 1 mL barcoded tubes of a solution with aCL IgA in phosphate buffer, containing fetal bovine serum, stabilizers and preservative. | QUANTA Flash® aCL IgA Controls | INOVA DIAGNOSTICS, INC. | |
| 33 | 08426950597353 | 701242 | 1. QUANTA Flash ß2GP1 IgA Low Control: 3 x 1 mL barcoded tubes of a solution wit 1. QUANTA Flash ß2GP1 IgA Low Control: 3 x 1 mL barcoded tubes of a solution with anti- ß2GP1 IgA in phosphate buffer, containing bovine serum albumin, stabilizers and preservative.2. QUANTA Flash ß2GP1 IgA High Control: 3 x 1 mL barcoded tubes of a solution with anti- ß2GP1 IgA in phosphate buffer, containing bovine serum albumin, stabilizers and preservative. | QUANTA Flash® β2GPI IgA Controls | INOVA DIAGNOSTICS, INC. | |
| 34 | 08426950597063 | 701147 | 1. QUANTA Flash Ro60 Negative Control: Two (2) barcode labeled tubes containing 1. QUANTA Flash Ro60 Negative Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to Ro60 in stabilizers and preservatives.2. QUANTA Flash Ro60 Positive Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to Ro60 in stabilizers, and preservatives. | QUANTA Flash® Ro60 Controls | INOVA DIAGNOSTICS, INC. | |
| 35 | 08426950597056 | 701152 | 1. QUANTA Flash SS-B Negative Control: Two (2) barcode labeled tubes containing 1. QUANTA Flash SS-B Negative Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to SS-B in stabilizers and preservatives.2. QUANTA Flash SS-B Positive Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to SS-B in stabilizers, and preservatives. | QUANTA Flash® SS-B Controls | INOVA DIAGNOSTICS, INC. | |
| 36 | 08426950596660 | 701262 | 1. QUANTA Flash Ro52 Negative Control: Two (2) barcode labeled tubes containing 1. QUANTA Flash Ro52 Negative Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to Ro52 in stabilizers and preservatives.2. QUANTA Flash Ro52 Positive Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to Ro52 in stabilizers, and preservatives. | QUANTA Flash® Ro52 Controls | INOVA DIAGNOSTICS, INC. | |
| 37 | 08426950596097 | 701197 | 1. QUANTA Flash Centromere Negative Control: Two (2) barcode labeled tubes conta 1. QUANTA Flash Centromere Negative Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to centromere in buffer, stabilizers, and preservatives.2. QUANTA Flash Centromere Positive Control: Two (2) barcode labeled tubes containing 0.5mL, ready to use reagent. Controls contain human antibodies to centromere in buffer, stabilizers, and preservatives. | QUANTA Flash® Centromere Controls | INOVA DIAGNOSTICS, INC. | |
| 38 | 08426950596073 | 701117 | 1. QUANTA Flash RNP Negative Control: Two (2) barcode labeled tubes containing 0 1. QUANTA Flash RNP Negative Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to RNP in stabilizers and preservatives.2. QUANTA Flash RNP Positive Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to RNP in stabilizers and preservatives. | QUANTA Flash® RNP Controls | INOVA DIAGNOSTICS, INC. | |
| 39 | 08426950596035 | 701122 | 1. QUANTA Flash Sm Negative Control: Two (2) barcode labeled tubes containing 0. 1. QUANTA Flash Sm Negative Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to Sm in stabilizers and preservatives.2. QUANTA Flash Sm Positive Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to Sm in stabilizers, and preservatives. | QUANTA Flash® Sm Controls | INOVA DIAGNOSTICS, INC. | |
| 40 | 08426950596011 | 701162 | 1. QUANTA Flash Jo-1 Negative Control: Two (2) barcode labeled tubes containing 1. QUANTA Flash Jo-1 Negative Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to Jo-1 in the buffer, stabilizers, and preservatives.2. QUANTA Flash Jo-1 Positive Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to Jo-1 in the buffer, stabilizers, and preservatives. | QUANTA Flash® Jo-1 Controls | INOVA DIAGNOSTICS, INC. | |
| 41 | 08426950595847 | 701112 | 1. QUANTA Flash DGP Screen Negative Control: Two (2) barcode labeled tubes with 1. QUANTA Flash DGP Screen Negative Control: Two (2) barcode labeled tubes with buffer containing human serum antibodies to DGP, prediluted, ready to use, 0.5mL (containing buffer, protein stabilizers, and preservatives).2. QUANTA Flash DGP Screen Positive Control: Two (2) barcode labeled tubes with buffer containing human serum antibodies to DGP, prediluted, ready to use, 0.5mL (containing buffer, protein stabilizers, and preservatives). | QUANTA Flash® DGP Screen Controls | INOVA DIAGNOSTICS, INC. | |
| 42 | 08426950595250 | 701247 | 1. QUANTA Flash ß2GP1 IgG Low Control 3 x 1 mL barcoded tubes of a solution with 1. QUANTA Flash ß2GP1 IgG Low Control 3 x 1 mL barcoded tubes of a solution with anti-ß2GP1 IgG in phosphate buffer containing bovine serum albimun, stabilizers and preservative.2. QUANTA Flash ß2GP1 IgG High Control 3 x 1 mL barcoded tubes of a solution with anti-ß2GP1 IgG in phosphate buffer containing bovine serum albumin, stabilizers and preservative. | QUANTA Flash® β2GPI IgG Controls | INOVA DIAGNOSTICS, INC. | |
| 43 | 08426950595038 | 701252 | 1. QUANTA Flash ß2GP1 IgM Low Control 3 x 1 mL barcoded tubes of a solution with 1. QUANTA Flash ß2GP1 IgM Low Control 3 x 1 mL barcoded tubes of a solution with anti-ß2GP1 IgM in phosphate buffer containing bovine serum albimun, stabilizers and preservative.2. QUANTA Flash ß2GP1 IgM High Control 3 x 1 mL barcoded tubes of a solution with anti-ß2GP1 IgM in phosphate buffer containing bovine serum albumin, stabilizers and preservative. | QUANTA Flash® β2GPI IgM Controls | INOVA DIAGNOSTICS, INC. | |
| 44 | 08426950594994 | 701237 | 1. QUANTA Flash aCL IgM Low Control 3 x 1 mL barcoded tubes of a solution with a 1. QUANTA Flash aCL IgM Low Control 3 x 1 mL barcoded tubes of a solution with aCL IgM in saline solution containing fetal bovine serum stabilizers and preservative.2. QUANTA Flash aCL IgM High Control 3 x 1 mL barcoded tubes of a solution with aCL IgM in saline solution containing fetal bovine serum, stabilizers and preservative. | QUANTA Flash® aCL IgM Controls | INOVA DIAGNOSTICS, INC. | |
| 45 | 08426950594888 | 701142 | 1. QUANTA Flash GBM Negative Control: Two (2) barcode labeled tubes with buffer 1. QUANTA Flash GBM Negative Control: Two (2) barcode labeled tubes with buffer containing human serum antibodies to GBM, prediluted, ready to use, 0.5mL (containing buffer, protein stabilizers, and preservatives).2. QUANTA Flash GBM Positive Control: Two (2) barcode labeled tubes with buffer containing human serum antibodies to GBM, prediluted, ready to use, 0.5mL (containing buffer, protein stabilizers, and preservatives). | QUANTA Flash® GBM Controls | INOVA DIAGNOSTICS, INC. | |
| 46 | 08426950594765 | 701107 | 1. QUANTA Flash h-tTG IgG Negative Control: Two (2) barcode labeled tubes contai 1. QUANTA Flash h-tTG IgG Negative Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to h-tTG in stabilizers and preservatives.2. QUANTA Flash h-tTG IgG Positive Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to h-tTG in stabilizers, and preservatives. | QUANTA Flash® h-tTG IgG Controls | INOVA DIAGNOSTICS, INC. | |
| 47 | 08426950594413 | 701172 | 1. QUANTA Flash DGP IgG Negative Control: Two (2) barcode labeled tubes containi 1. QUANTA Flash DGP IgG Negative Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human IgG antibodies to DGP in buffer, protein stabilizers, and preservatives.2. QUANTA Flash DGP IgG Positive Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human IgG antibodies to DGP in buffer, protein stabilizers, and preservatives. | QUANTA Flash® DGP IgG Controls | INOVA DIAGNOSTICS, INC. | |
| 48 | 08426950566380 | 701257 | 1. QUANTA Flash ENA7 Negative Control: Two (2) barcode labeled tubes containing 1. QUANTA Flash ENA7 Negative Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to ENA7 in buffer, stabilizers, and preservatives.2. QUANTA Flash ENA7 Positive Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to ENA7 in buffer, stabilizers, and preservatives." | QUANTA Flash® ENA7 Controls | INOVA DIAGNOSTICS, INC. | |
| 49 | 08426950557579 | 701167 | 1. QUANTA Flash DGP IgA Calibrator 1: Two (2) barcode labeled tubes containing 0 1. QUANTA Flash DGP IgA Calibrator 1: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human IgA antibodies to DGP in buffer, protein stabilizers, and preservatives. 2. QUANTA Flash DGP IgA Calibrator 2: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human IgA antibodies to DGP in buffer, protein stabilizers, and preservatives. | QUANTA Flash® DGP IgA Controls | INOVA DIAGNOSTICS, INC. | |
| 50 | 08426950554561 | 701132 | 1. QUANTA Flash MPO Negative Control: Two (2) barcode labeled tubes with buffer 1. QUANTA Flash MPO Negative Control: Two (2) barcode labeled tubes with buffer containing human serum antibodies to MPO, prediluted, ready to use, 0.5mL (containing buffer, protein stabilizers, and preservatives).2. QUANTA Flash MPO Positive Control: Two (2) barcode labeled tubes with buffer containing human serum antibodies to MPO, prediluted, ready to use, 0.5mL (containing buffer, protein stabilizers, and preservatives). | QUANTA Flash® MPO Controls | INOVA DIAGNOSTICS, INC. |