| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00657498300039 | G3000-CONTCUV | G3000-CONTCUV | The HemoPoint® H2 system is intended for the quantitative determination of hemog The HemoPoint® H2 system is intended for the quantitative determination of hemoglobin (Hgb) in whole blood of adults, infants, and children in a professional point-of-care setting. It consists of a dedicated photometer and individual, single-use microcuvettes filled with reagents. | GKR | System, Hemoglobin, Automated | 2 | HemoPoint H2 |
| 2 | 00657498002261 | 7014-204 | 7014-204 | Blood Glucose Control Solution is intended for use with EKF Diagnostic’s Blood G Blood Glucose Control Solution is intended for use with EKF Diagnostic’s Blood Glucose Test Strip. It is used to check that the meter and test strips are working together properly. It is important to do control solution tests routinely to ensure getting accurate results. | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Blood Glucose Control Solution |
| 3 | 00657498001776 | 20270479 | 20270479 | For use to wash the ISE module and sample probe. | Sirrus® ISE Wash Solution | |||
| 4 | 00657498001530 | S0370-600 | S0370-600 | For the Quantitative Colorimetric Determination of Iron in Serum. | JIY | Photometric Method, Iron (Non-Heme) | 1 | Sirrus® Total Iron LiquiColor® |
| 5 | 00657498001509 | S0250-750 | S0250-750 | For the Quantitative Colorimetric Determination of Total Protein in Serum. | CEK | Biuret (Colorimetric), Total Protein | 2 | Sirrus® Total Protein LiquiColor® |
| 6 | 00657498001479 | S0190-750 | S0190-750 | For the Quantitative Determination of Bicarbonate (CO2) in Serum and Plasma. | KHS | Enzymatic, Carbon-Dioxide | 2 | Sirrus® Bicarbonate (CO2) LiquiColor® |
| 7 | 00657498001356 | 1430-050 | 1430-050 | A Qualitative Immunoassay for the Detection of Human Chorionic Gonadotropin (hCG A Qualitative Immunoassay for the Detection of Human Chorionic Gonadotropin (hCG) in Urine. | JHI | Visual, Pregnancy Hcg, Prescription Use | TRUE® 20 hCG | |
| 8 | 00657498001141 | 1012-030 | 1012-030 | Quantitative-Enzymatic-Colorimetric Determination of Total and HDL Cholesterol i Quantitative-Enzymatic-Colorimetric Determination of Total and HDL Cholesterol in Serum or Plasma. | CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 | Cholesterol Standard (200 mg/dL) |
| 9 | 00657498001127 | 0550-605 | 0550-605 | For use as a multi-calibrator serum to calibrate different chemistry reagent use For use as a multi-calibrator serum to calibrate different chemistry reagent used in manual and automated clinical chemistry methods. | JIX | Calibrator, Multi-Analyte Mixture | 2 | Ser-T-Cal Multicalibrator |
| 10 | 00657498001042 | 2200-225 | 2200-225 | For the Quantitative Enzymatic-Colorimetric Determination of Triglycerides in Se For the Quantitative Enzymatic-Colorimetric Determination of Triglycerides in Serum or Plasma. | CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 1 | Triglyceride LiquiColor® (Mono) |
| 11 | 00657498001035 | 2200-430 | 2200-430 | For the Quantitative Enzymatic-Colorimetric Determination of Triglycerides in Se For the Quantitative Enzymatic-Colorimetric Determination of Triglycerides in Serum or Plasma. | CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 1 | Triglyceride LiquiColor® (Mono) |
| 12 | 00657498000861 | 2370-401 | 2370-401 | Stanbio Glycated Serum Protein (GSP) Control Kit is intended to be used for qual Stanbio Glycated Serum Protein (GSP) Control Kit is intended to be used for quality control procedures in examining the accuracy and precision of Stanbio Glycated Serum Protein LiquiColor® Assay (REF 2350-062). | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Glycated Serum Protein Bi-Level Control Set |
| 13 | 00657498000847 | 2350-062 | 2350-062 | Stanbio Glycated Serum Protein (GSP) Assay in conjunction with Stanbio Glycated Stanbio Glycated Serum Protein (GSP) Assay in conjunction with Stanbio Glycated Serum Protein calibrator, are intended for the quantitative determination of glycated serum proteins (GSP; glycated albumin; fructosamine) in serum. The measurement of glycated serum proteins is useful for monitoring diabetic patients. | LCP | Assay, Glycosylated Hemoglobin | 2 | Glycated Serum Protein (GSP) LiquiColor® |
| 14 | 00657498000533 | 2460-605 | 2460-605 | For Use as Controls in Quantitative Procedures for Acetaminophen, Salicylate, an For Use as Controls in Quantitative Procedures for Acetaminophen, Salicylate, and ß-Hydroxybutyrate. | DIF | Drug Mixture Control Materials | 1 | TDM/B-Hydroxybutyrate Tri-Level Controls |
| 15 | 00657498000526 | B2440-180 | B2440-180 | For the Quantitative Determination of ß-Hydroxybutyrate in Serum or Plasma. | JIN | Nitroprusside, Ketones (Urinary, Non-Quant.) | 1 | Synchron® CX/LX/DX B-Hydroxybutyrate LiquiColor® |
| 16 | 00657498000519 | 2440-058 | 2440-058 | For the Quantitative Determination of ß-Hydroxybutyrate in Human Serum or Plasma. | JIN | Nitroprusside, Ketones (Urinary, Non-Quant.) | 1 | B-Hydroxybutyrate LiquiColor® |
| 17 | 00657498000489 | 2970-430 | 2970-430 | For the Quantitative Determination of Amylase in Serum and Urine. | JFJ | Catalytic Methods, Amylase | 2 | a-Amylase LiquiColor® |
| 18 | 00657498000120 | 202000 | 202000 | STAT-Site® Diluent is intended to be used with the STAT-Site® M β-HB Test Strips STAT-Site® Diluent is intended to be used with the STAT-Site® M β-HB Test Strips or KetoSite® Test Cards to dilute specimens containing high levels of β-hydroxybutyrate into the test range of 0 – 2 mM. Additionally, the diluent helps to eliminate possible matrix effects caused by interfering substances such as acetoacetate. | JIN | Nitroprusside, Ketones (Urinary, Non-Quant.) | 1 | STAT-Site Diluent |
| 19 | 00657498000014 | 6300-020 | 6300-020 | For the Qualitative Detection of IgG Antibodies to Helicobacter pylori (H. pylor For the Qualitative Detection of IgG Antibodies to Helicobacter pylori (H. pylori) in Whole blood, Serum or Plasma. | LYR | Helicobacter Pylori | RELY® H.Pylori | |
| 20 | 00657498301654 | 3016-050 | 3016-050 | For the quantitative determination of hemoglobin in capillary, venous or arteria For the quantitative determination of hemoglobin in capillary, venous or arterial whole blood. | GKR | System, Hemoglobin, Automated | HemoPoint® H2 n•x•t Microcuvettes | |
| 21 | 00657498001837 | S0130-600 | S0130-600 | For the Quantitative Determination of Magnesium in Serum, Plasma or Urine. | JGJ | Photometric Method, Magnesium | 1 | Sirrus® Magnesium LiquiColor® |
| 22 | 00657498001561 | S0590-540 | S0590-540 | For the Quantitative Determination of High Density Lipoprotein (HDL) Cholesterol For the Quantitative Determination of High Density Lipoprotein (HDL) Cholesterol in Human Serum. | LBS | Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl | 1 | Sirrus® Direct HDL Cholesterol LiquiColor® |
| 23 | 00657498001523 | S0360-200 | S0360-200 | For the Quantitative Determination of Glycohemoglobin (HbA1c) in human blood. | LCP | Assay, Glycosylated Hemoglobin | 2 | Sirrus® Direct Gylcohemoglobin (HbA1c) |
| 24 | 00657498001486 | S0230-600 | S0230-600 | For the Quantitative Colorimetric Determination of Total Bilirubin in Serum and Plasma. | JFM | Enzymatic Method, Bilirubin | 2 | Sirrus® Total Bilirubin LiquiColor® |
| 25 | 00657498001318 | 1230-025 | 1230-025 | For the qualitative determination of human chorionic gonadotropin (hCG) in serum For the qualitative determination of human chorionic gonadotropin (hCG) in serum or urine to aid in the early detection of pregnancy. | JHI | Visual, Pregnancy Hcg, Prescription Use | QuPID® Plus hCG Pregnancy Test | |
| 26 | 00657498001301 | 1170-500 | 1170-500 | Carbon flocculation slide test for the qualitative and quantitative determinatio Carbon flocculation slide test for the qualitative and quantitative determination of reagin antibodies in serum or plasma. | GMQ | Antigens, Nontreponemal, All | 2 | RPR Quicktest |
| 27 | 00657498001295 | 1170-100 | 1170-100 | Carbon flocculation slide test for the qualitative and quantitative determinatio Carbon flocculation slide test for the qualitative and quantitative determination of reagin antibodies in serum or plasma. | GMQ | Antigens, Nontreponemal, All | 2 | RPR Quicktest |
| 28 | 00657498001219 | G428-86 | G428-86 | Use as a control serum to monitor the accuracy and precision of manual and autom Use as a control serum to monitor the accuracy and precision of manual and automated methods used in clinical chemistry. | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Ser-T-Fy 2, Level 2 Control |
| 29 | 00657498001066 | 2100-225 | 2100-225 | For the Quantitative Enzymatic- Colorimetric Determination of Triglycerides in S For the Quantitative Enzymatic- Colorimetric Determination of Triglycerides in Serum or Plasma. | CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 1 | Triglyceride LiquiColor® |
| 30 | 00657498001059 | 2100-430 | 2100-430 | For the Quantitative Enzymatic- Colorimetric Determination of Triglycerides in S For the Quantitative Enzymatic- Colorimetric Determination of Triglycerides in Serum or Plasma. | CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 1 | Triglyceride LiquiColor® |
| 31 | 00657498000809 | 1060-500 | 1060-500 | For the Quantitative Determination of Glucose in Serum or Plasma. | CFR | Hexokinase, Glucose | 2 | Glucose Liqui-UV® |
| 32 | 00657498000632 | 0210-250 | 0210-250 | Quantitative Colorimetric Determination of Chloride in Serum, Plasma, Urine and CSF. | CHJ | Mercuric Thiocyanate, Colorimetry, Chloride | 2 | Chloride LiquiColor® |
| 33 | 00657498000236 | 3025-050 | 3025-050 | For the quantitative determination of hemoglobin in capillary, venous or arteria For the quantitative determination of hemoglobin in capillary, venous or arterial whole blood. | GKR | System, Hemoglobin, Automated | n•x•t Microcuvette | |
| 34 | 00657498000168 | 503000 | 503000 | A bi-level reference control intended for use on STAT-Site® and HemoSite® hemogl A bi-level reference control intended for use on STAT-Site® and HemoSite® hemoglobin testing systems, including the STAT-Site® MHgb Test System. | JPK | Mixture, Hematology Quality Control | 2 | STAT-Site Hgb Controls |
| 35 | 00657498000113 | 303500 | 303500 | The STAT-Site® Linearity Check is intended to be used to perform a linearity eva The STAT-Site® Linearity Check is intended to be used to perform a linearity evaluation of the STAT-Site® Mβ-HB Test Strips /KetoSite® Test Cards by making a series of dilutions using STAT-Site® Diluent (Catalog No. 202000). Both the STAT-Site® Mβ-HB Test Strips and KetoSite® Test Cards are used in the measurement of β-hydroxybutyrate with the STAT-Site® Mβ-HB and STAT-Site® Meter. | JIN | Nitroprusside, Ketones (Urinary, Non-Quant.) | 1 | STAT-Site Linearity Check |
| 36 | 00657498002377 | 3063-006 | 3063-006 | A single level reference control intended for use on Hemo Control Hemoglobin Mea A single level reference control intended for use on Hemo Control Hemoglobin Measuring system. | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | HGB Controls - High |
| 37 | 00657498002360 | 3063-003 | 3063-003 | A single level reference control intended for use on Hemo Control Hemoglobin Mea A single level reference control intended for use on Hemo Control Hemoglobin Measuring system. | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | HGB Controls - High |
| 38 | 00657498002216 | 7010-100 | 7010-100 | The EKF Diagnostics STAT-Site WB Blood Glucose Test Strip, when used together wi The EKF Diagnostics STAT-Site WB Blood Glucose Test Strip, when used together with the EKF Diagnostics STAT-Site WB Dual Analyte Measurement System, is for multiple patient use in professional healthcare settings. It is intended for use by professionals in testing with capillary, venous and neonatal capillary heelstick whole blood samples. It should not be used for the diagnosis of or screening for diabetes. | LFR | Glucose Dehydrogenase, Glucose | STAT-Site WB Blood Glucose Test Strips | |
| 39 | 00657498002209 | 7010-050 | 7010-050 | The EKF Diagnostics STAT-Site WB Blood Glucose Test Strip, when used together wi The EKF Diagnostics STAT-Site WB Blood Glucose Test Strip, when used together with the EKF Diagnostics STAT-Site WB Dual Analyte Measurement System, is for multiple patient use in professional healthcare settings. It is intended for use by professionals in testing with capillary, venous and neonatal capillary heelstick whole blood samples. It should not be used for the diagnosis of or screening for diabetes. | LFR | Glucose Dehydrogenase, Glucose | STAT-Site WB Blood Glucose Test Strips | |
| 40 | 00657498002193 | 7010-025 | 7010-025 | The EKF Diagnostics STAT-Site WB Blood Glucose Test Strip, when used together wi The EKF Diagnostics STAT-Site WB Blood Glucose Test Strip, when used together with the EKF Diagnostics STAT-Site WB Dual Analyte Measurement System, is for multiple patient use in professional healthcare settings. It is intended for use by professionals in testing with capillary, venous and neonatal capillary heelstick whole blood samples. It should not be used for the diagnosis of or screening for diabetes. | LFR | Glucose Dehydrogenase, Glucose | STAT-Site WB Blood Glucose Test Strips | |
| 41 | 00657498002131 | 4000-100 | 4000-100 | Nitro-tab Ketone Tablets are for the semi-quantitative determination of ketones Nitro-tab Ketone Tablets are for the semi-quantitative determination of ketones (acetoacetic acid and acetone) in urine, serum, plasma, and whole blood. | JIN | Nitroprusside, Ketones (Urinary, Non-Quant.) | Nitro-tab Ketone Tablets | |
| 42 | 00657498002025 | 3060-101N | 3060-101N | A single level reference control intended for use on HemoPoint® H2 Hemoglobin te A single level reference control intended for use on HemoPoint® H2 Hemoglobin testing system. | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Hgb Control, Normal |
| 43 | 00657498001905 | 20270476 | 20270476 | Ion-Selective Electrode for the measurement of potassium in serum. | CEM | Electrode, Ion Specific, Potassium | 2 | ISE Potassium Electrode |
| 44 | 00657498001790 | A469-98 | A469-98 | To provide calibration points for the Sodium, Potassium, and Chloride electrodes To provide calibration points for the Sodium, Potassium, and Chloride electrodes on the ISE module of Roche Cobas Chemistry Systems. | JIX | Calibrator, Multi-Analyte Mixture | 2 | Standard 2 |
| 45 | 00657498001752 | 20270477 | 20270477 | The ISE Calibrator 1 for the Sirrus® is an in vitro diagnostic calibrator system The ISE Calibrator 1 for the Sirrus® is an in vitro diagnostic calibrator system intended for use on the Sirrus® Chemistry Analyzer to calibrate the ISE module option for chloride, potassium and sodium. | JIX | Calibrator, Multi-Analyte Mixture | 2 | Sirrus® ISE Calibrator 1 |
| 46 | 00657498001745 | 2211-600 | 2211-600 | For use as a probe cleaner on the Sirrus® Chemistry Analyzer. | Sirrus® Probe Cleaner | |||
| 47 | 00657498001639 | S2200-750 | S2200-750 | For the Quantitative Colorimetric Determination of Triglycerides in Serum and Plasma. | CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 1 | Sirrus® Triglyceride LiquiColor® |
| 48 | 00657498001615 | S1060-600 | S1060-600 | For the Quantitative Determination of Glucose in Serum, Plasma, CSF or Urine. | CFR | Hexokinase, Glucose | 2 | Sirrus® Glucose Liqui-UV® |
| 49 | 00657498001257 | 1130-100 | 1130-100 | Latex agglutination slide test for the Qualitative and Semi-quantitative determi Latex agglutination slide test for the Qualitative and Semi-quantitative determination of C-Reactive Protein in non-diluted serum. | DCN | System, Test, C-Reactive Protein | 2 | RaPET® CRP |
| 50 | 00657498001240 | 1130-050 | 1130-050 | Latex agglutination slide test for the Qualitative and Semi-quantitative determi Latex agglutination slide test for the Qualitative and Semi-quantitative determination of C-Reactive Protein in non-diluted serum. | DCN | System, Test, C-Reactive Protein | 2 | RaPET® CRP |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | B350GSD0113000 | GSD01-1300 | Gold Standard Diagnostics Anti-nuclear Antibody (ANA) Screening Test Kit | Gold Standard Diagnostics Anti-nuclear Antibody (ANA) Screening Test Kit | GOLD STANDARD DIAGNOSTICS CORPORATION | |
| 2 | B24235E6PHUE010 | 35-E6PHU-E01 | 35-E6PHU-E01 | The ENA-6Pro ELISA is a solid phase enzyme immunoassay for the separate semiquan The ENA-6Pro ELISA is a solid phase enzyme immunoassay for the separate semiquantitative detection of IgG antibodies against six cellular and nuclear antigens in human serum. The wells are coated with recombinant SS-B, SS-A 52 kDa, Scl 70, Jo-1 and highly purified native human snRNP/Sm, Sm and SS-A 60 kDa. The assay is an aid in the differential diagnosis of systemic rheumatic diseases and should be used in conjunction with other serological tests and clinical findings. | ENA-6Pro ELISA | AMERICAN LABORATORY PRODUCTS COMPANY, LTD. |
| 3 | B24235ANAHUE010 | 35-ANAHU-E01 | 35-ANAHU-E01 | The ANA-8Pro ELISA is a solid phase enzyme immunoassay for the separate qualitat The ANA-8Pro ELISA is a solid phase enzyme immunoassay for the separate qualitative detection of IgG antibodies against eight cellular and nuclear antigens in human serum. The wells are separately coated with recombinant 70 kDa U1 snRNP, SS-B, SS-A 52 kDa, Scl 70, centromere protein B (CenpB), Jo-1 and highly purified native human snRNP/Sm, Sm and SS-A 60 kDa. The assay is an aid in the differential diagnosis of systemic rheumatic diseases and should be used in conjunction with other serological tests and clinical findings. | ANA-8Pro ELISA | AMERICAN LABORATORY PRODUCTS COMPANY, LTD. |
| 4 | 08426950595632 | 701198 | 1. 1 QUANTA Flash Centromere Reagent Cartridge2. 1 Resuspension buffer 3. 1 Transfer pipet | QUANTA Flash® Centromere Reagents | INOVA DIAGNOSTICS, INC. | |
| 5 | 08426950593744 | 708525 | 1. 1x ssDNA ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL pred 1. 1x ssDNA ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted ssDNA ELISA Low Positive4. 1 x1.2mL prediluted ssDNA ELISA High Positive5. 1 x50mL HRP Sample Diluent6. 1 x25mL HRP Wash Concentrate, 40x concentrate7. 1x 10mL HRP IgG Conjugate, (goat), anti-human IgG8. 1x 10mL TMB Chromogen9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid" | QUANTA Lite® ssDNA ELISA | INOVA DIAGNOSTICS, INC. | |
| 6 | 08426950544128 | 708770 | (CENP-A & CENP-B)1.1x Centromere ELISA microwell plate (12-1 x 8 wells), with ho (CENP-A & CENP-B)1.1x Centromere ELISA microwell plate (12-1 x 8 wells), with holder2.1x 1.2mL prediluted ELISA Negative Control 3.1x 1.2mL prediluted Centromere ELISA Low Positive4.1x 1.2mL prediluted Centromere ELISA High Positive5.1x 50mL HRP Sample Diluent6.1 x25mL HRP Wash Concentrate, 40x concentrate7.1x 10mL HRP IgG Conjugate, (goat), anti-human IgG8.1x 10mL TMB Chromogen9.1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid | QUANTA Lite® Centromere ELISA | INOVA DIAGNOSTICS, INC. | |
| 7 | 07340058410509 | FAID200 | FAID200 | DIASTAT ENA Profile | EURO-DIAGNOSTICA AB | |
| 8 | 07333066014845 | DECC056370 | DECC056370 | EliA Scl-70S Well | EliA Scl-70S Well | PHADIA AB |
| 9 | 07333066014586 | DECC055070 | DECC055070 | EliA Jo-1 Well | EliA Jo-1 Well | PHADIA AB |
| 10 | 07333066014579 | DECC055060 | DECC055060 | EliA Scl-70 Well | EliA Scl-70 Well | PHADIA AB |
| 11 | 05391516747165 | 2337770 | 2337770 | Captia™ Histone | Trinity Biotech | CLARK LABORATORIES, INC. |
| 12 | 05391516743778 | 2337370 | 2337370 | Captia™ Sm/RNP | Trinity Biotech | CLARK LABORATORIES, INC. |
| 13 | 05391516743761 | 2337270 | 2337270 | Captia™ Smith (Sm) | Trinity Biotech | CLARK LABORATORIES, INC. |
| 14 | 05391516743747 | 2337070 | 2337070 | Captia™ SSA (Ro) | Trinity Biotech | CLARK LABORATORIES, INC. |
| 15 | 04260157080638 | ORG600 | ORG600 | ANA Detect is an ELISA test system for the qualitative measurement of IgG class ANA Detect is an ELISA test system for the qualitative measurement of IgG class autoantibodies against SS-A-52 (Ro-52), SS-A-60 (Ro-60), SS-B (La), RNP/Sm, RNP-70, RNP-A, RNP-C, Sm-BB, Sm-D, Sm-E, Sm-F, Sm-G, Scl-70, Jo-1, dsDNA, ssDNA, ssDNA, polynucleosomes, mononucleosomes, histone complex, histone H1, histone H2A, histone H2B, histone 3, histone H4, Pm-Scl-100 and centromere B in human serum or plasma samples. This product is intended for professional in vitro diagnostic use only as an aid in the diagnosis of certain systematic rheumatic diseases. | ANA DETECT | ORGENTEC DIAGNOSTIKA GMBH |
| 16 | 04260157080102 | ORG513 | ORG513 | ANTI-JO-1 IS AN EILSA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS ANTI-JO-1 IS AN EILSA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS AUTOANTIBODIES AGAINST JO-1 IN HUMAN SERUM OR PLASMA. THIS PRODUCT IS INTENDED FOR PROFESSIONAL IN VITRO DIAGNOSTIC USE ONLY. | ANTI-JO-1 | ORGENTEC DIAGNOSTIKA GMBH |
| 17 | 04260157080096 | ORG512 | ORG512 | ANTI-SCL-70 IS AN ELISA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLAS ANTI-SCL-70 IS AN ELISA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS AUTOANTIBODIES AGAINST SCL-70 IN HUMAN SERUM OR PLASMA. THIS PRODUCT IS INTENDED FOR PRFESSIONAL IN VITRO DIAGNOSTIC USE ONLY. | ANTI-SCI-70 | ORGENTEC DIAGNOSTIKA GMBH |
| 18 | 04260157080089 | ORG511 | ORG511 | ANTI-RPN/SM IS AN ELISA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLAS ANTI-RPN/SM IS AN ELISA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS AUTOANTIBODIES AGAINST RNP/SM IN HUMAN SERUM OR PLASMA. THIS PRODUCT IS INTENDED FOR PROFESSIONAL IN VITRO DIAGNOSTIC USE ONLY. | ANTI-RPN/SM | ORGENTEC DIAGNOSTIKA GMBH |
| 19 | 04260157080072 | ORG510 | ORG510 | ANTI-SM IS AN ELISA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS AU ANTI-SM IS AN ELISA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS AUTOANTIBODIES AGAINST SM IN HUMAN SERUM OR PLASMA. THIS PRODUCT IS INTENDED FOR PROFESSIONAL IN VITRO DIAGNOSTIC USE ONLY. | ANTI-SM | ORGENTEC DIAGNOSTIKA GMBH |
| 20 | 04260157080065 | ORG509 | ORG509 | ANTI-SS-B IS AN ELISA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS ANTI-SS-B IS AN ELISA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS AUTOANTIBODIES AGAINST SS-B (La) IN HUMAN SERUM OR PLASMA. THIS PRODUCT IS INTENDED FOR PROFESSIONAL IN VITRO DIAGNOSTIC USE ONLY. | ANTI-SS-B | ORGENTEC DIAGNOSTIKA GMBH |
| 21 | 04260157080058 | ORG508 | ORG508 | ANTI-SS-A IS AN ELISA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS ANTI-SS-A IS AN ELISA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS AUTOANTIBODIES AGAINST SS-A (52 AND 60kDa) IN HUMAN SERUM OR PLASMA. THIS PRODUCT IS INTENDED FOR PROFESSIONAL IN VITRO DIAGNOSTIC USE ONLY. | ANTI-SS-A | ORGENTEC DIAGNOSTIKA GMBH |
| 22 | 04250289503013 | 7113US | 7113US | AESKULISA Jo-1 is a solid phase enzyme immunoassay with recombinant human histid AESKULISA Jo-1 is a solid phase enzyme immunoassay with recombinant human histidyltRNA-synthetase (HRS) for the quantitative and qualitative detection of antibodies against Jo-1 (named after the prototype patient) in human serum. Human sera with anti-Jo-1 antibodies solely recognize HRS of higher eukaryotes and react with highest affinity with the human enzyme. The assay is a tool in the diagnosis of polymyositis and dermatomyositis. | AESKULISA® Jo-1 | AESKU.DIAGNOSTICS GMBH & CO. KG |
| 23 | 04250289503006 | 7112US | 7112US | AESKULISA Cenp-B is a solid phase enzyme immunoassay employing purified recombin AESKULISA Cenp-B is a solid phase enzyme immunoassay employing purified recombinant human 80 kDa centromere protein B (Cenp-B) for the quantitative and qualitative detection of IgG antibodies against Cenp-B in human serum. The assay ensures the highest specificity and sensitivity for the detection of antibodies against centromere protein B, which serves as an aid in the diagnosis of systemic sclerosis and CREST syndrome. | AESKULISA® Cenp-B | AESKU.DIAGNOSTICS GMBH & CO. KG |
| 24 | 04250289502993 | 7111US | 7111US | AESKULISA Scl-70 is a solid phase enzyme immunoassay with human recombinant 70 k AESKULISA Scl-70 is a solid phase enzyme immunoassay with human recombinant 70 kDa fragment of DNA topoisomerase I for the quantitative and qualitative detection of antibodies against Scl-70 (70 kDa scleroderma antigen) in human serum. The assay is a tool in the differential diagnosis of systemic sclerosis. | AESKULISA® Scl-70 | AESKU.DIAGNOSTICS GMBH & CO. KG |
| 25 | 04250289502986 | 7110US | 7110US | AESKULISA SS-B is a solid phase enzyme immunoassay employing human recombinant L AESKULISA SS-B is a solid phase enzyme immunoassay employing human recombinant La-antigen/ SS-B for the quantitative and qualitative detection of antibodies against Laantigen / SS-B in human serum. The assay is a tool in the diagnosis of Sjögren`s syndrome (SS) and systemic lupus erythematosus (SLE). | AESKULISA® SS-B | AESKU.DIAGNOSTICS GMBH & CO. KG |
| 26 | 04250289502979 | 7107US | 7107US | AESKULISA SS-A is a solid phase enzyme immunoassay for the quantitative and qual AESKULISA SS-A is a solid phase enzyme immunoassay for the quantitative and qualitative detection of antibodies against Ro/ SS-A in human serum. The assay employs human Ro/SS-A antigen composed of highly purified native 60kDa and recombinant human 52 kDa Ro/SS-A protein. Anti-SS-A antibodies are species-specific (directed against human protein only) and preferentially react with the native 60kDa molecule where as most antibodies to the 52 kDa protein prefer the denatured molecule. The assay is a tool in the diagnosis of Sjögren`s syndrome (SS) and systemic lupus erythematosus (SLE). | AESKULISA® SS-A | AESKU.DIAGNOSTICS GMBH & CO. KG |
| 27 | 04250289502962 | 7106US | 7106US | AESKULISA Sm is a solid phase enzyme immunoassay with highly purified native Smi AESKULISA Sm is a solid phase enzyme immunoassay with highly purified native Smith antigen (Sm) from human eukaryotic cells (HeLa) for the quantitative and qualitative detection of antibodies against Sm in human serum. Anti-Sm antibodies recognize specific conformational epitopes only accessible on native human Sm. The assay is a tool in the differential diagnosis of systemic lupus erythematosus (SLE). | AESKULISA® Sm | AESKU.DIAGNOSTICS GMBH & CO. KG |
| 28 | 04250289502955 | 7105US | 7105US | AESKULISA snRNP-C is a solid phase enzyme immunoassay for the quantitative and q AESKULISA snRNP-C is a solid phase enzyme immunoassay for the quantitative and qualitative detection of antibodies against the snRNP complex in human serum. The assay employs native human U1-snRNP complex highly purified from the cell-line HeLa. The U1-snRNP complex comprises the Smith antigen (Sm) and RNPs, the 70kDa U1specific protein plus protein A and C. The assay is a tool for the diagnosis of mixed connective tissue diseases (MCTD) and systemic lupus erythematosus (SLE) | AESKULISA® snRNP-C | AESKU.DIAGNOSTICS GMBH & CO. KG |
| 29 | 04250289502948 | 7104US | 7104US | AESKULISA U1-70 is a solid phase enzyme immunoassay employing recombinant human AESKULISA U1-70 is a solid phase enzyme immunoassay employing recombinant human 70 kDa protein of the U1-snRNP complex for the quantitative and qualitative detection of antibodies against the 70 kDa U1-RNP in human serum. The assay is a tool in the diagnosis of mixed connective tissue diseases (MCTD) and systemic lupus erythematosus (SLE). | AESKULISA® U1-70 | AESKU.DIAGNOSTICS GMBH & CO. KG |
| 30 | 04250289502931 | 7103US | 7103US | AESKULISA ENA-6Pro is a solid phase enzyme immunoassay for the separate semiquan AESKULISA ENA-6Pro is a solid phase enzyme immunoassay for the separate semiquantitative detection of IgG antibodies against six cellular and nuclear antigens in human serum. The wells are coated with recombinant SS-B, SS-A 52 kDa, Scl 70, Jo-1 and highly purified native human snRNP/Sm, Sm and SS-A 60 kDa. The assay is a tool in the differential diagnosis of systemic rheumatic diseases. | AESKULISA® ENA-6Pro | AESKU.DIAGNOSTICS GMBH & CO. KG |
| 31 | 04250289502917 | 7101US | 7101US | AESKULISA ANA-8Pro is a solid phase enzyme immunoassay for the separate qualitat AESKULISA ANA-8Pro is a solid phase enzyme immunoassay for the separate qualitative detection of IgG antibodies against eight cellular and nuclear antigens in human serum. The wells are separately coated with recombinant 70 kDa U1 snRNP, SS-B, SS-A 52 kDa, Scl 70, centromere protein B (CenpB), Jo-1 and highly purified native human snRNP/Sm, Sm and SS-A 60 kDa. The assay is a tool in the differential diagnosis of systemic rheumatic diseases. | AESKULISA® ANA-8Pro | AESKU.DIAGNOSTICS GMBH & CO. KG |
| 32 | 04250289500555 | 3113 | AESKULISA Jo-1 is a solid phase enzyme immunoassay with recombinant human histid AESKULISA Jo-1 is a solid phase enzyme immunoassay with recombinant human histidyltRNA-synthetase (HRS) for the quantitative and qualitative detection of antibodies against Jo-1 (named after the prototype patient) in human serum. Human sera with anti-Jo-1 antibodies solely recognize HRS of higher eukaryotes and react with highest affinity with the human enzyme. The assay is a tool in the diagnosis of polymyositis and dermatomyositis. | AESKULISA® Jo-1 | AESKU.DIAGNOSTICS GMBH & CO. KG | |
| 33 | 04250289500548 | 3112 | AESKULISA Cenp-B is a solid phase enzyme immunoassay employing purified recombin AESKULISA Cenp-B is a solid phase enzyme immunoassay employing purified recombinant human 80 kDa centromere protein B (Cenp-B) for the quantitative and qualitative detection of IgG antibodies against Cenp-B in human serum. The assay ensures the highest specificity and sensitivity for the detection of antibodies against centromere protein B, which serves as an aid in the diagnosis of systemic sclerosis and CREST syndrome. | AESKULISA® Cenp-B | AESKU.DIAGNOSTICS GMBH & CO. KG | |
| 34 | 04250289500531 | 3111 | AESKULISA Scl-70 is a solid phase enzyme immunoassay with human recombinant 70 k AESKULISA Scl-70 is a solid phase enzyme immunoassay with human recombinant 70 kDa fragment of DNA topoisomerase I for the quantitative and qualitative detection of antibodies against Scl-70 (70 kDa scleroderma antigen) in human serum. The assay is a tool in the differential diagnosis of systemic sclerosis. | AESKULISA® Scl-70 | AESKU.DIAGNOSTICS GMBH & CO. KG | |
| 35 | 04250289500524 | 3110 | AESKULISA SS-B is a solid phase enzyme immunoassay employing human recombinant L AESKULISA SS-B is a solid phase enzyme immunoassay employing human recombinant La-antigen/ SS-B for the quantitative and qualitative detection of antibodies against Laantigen / SS-B in human serum. The assay is a tool in the diagnosis of Sjögren`s syndrome (SS) and systemic lupus erythematosus (SLE). | AESKULISA® SS-B | AESKU.DIAGNOSTICS GMBH & CO. KG | |
| 36 | 04250289500494 | 3107 | AESKULISA SS-A is a solid phase enzyme immunoassay for the quantitative and qual AESKULISA SS-A is a solid phase enzyme immunoassay for the quantitative and qualitative detection of antibodies against Ro/ SS-A in human serum. The assay employs human Ro/SS-A antigen composed of highly purified native 60kDa and recombinant human 52 kDa Ro/SS-A protein. Anti-SS-A antibodies are species-specific (directed against human protein only) and preferentially react with the native 60kDa molecule where as most antibodies to the 52 kDa protein prefer the denatured molecule. The assay is a tool in the diagnosis of Sjögren`s syndrome (SS) and systemic lupus erythematosus (SLE). | AESKULISA® SS-A | AESKU.DIAGNOSTICS GMBH & CO. KG | |
| 37 | 04250289500487 | 3106 | AESKULISA Sm is a solid phase enzyme immunoassay with highly purified native Smi AESKULISA Sm is a solid phase enzyme immunoassay with highly purified native Smith antigen (Sm) from human eukaryotic cells (HeLa) for the quantitative and qualitative detection of antibodies against Sm in human serum. Anti-Sm antibodies recognize specific conformational epitopes only accessible on native human Sm. The assay is a tool in the differential diagnosis of systemic lupus erythematosus (SLE). | AESKULISA® Sm | AESKU.DIAGNOSTICS GMBH & CO. KG | |
| 38 | 04250289500470 | 3105 | AESKULISA snRNP-C is a solid phase enzyme immunoassay for the quantitative and q AESKULISA snRNP-C is a solid phase enzyme immunoassay for the quantitative and qualitative detection of antibodies against the snRNP complex in human serum. The assay employs native human U1-snRNP complex highly purified from the cell-line HeLa. The U1-snRNP complex comprises the Smith antigen (Sm) and RNPs, the 70kDa U1specific protein plus protein A and C. The assay is a tool for the diagnosis of mixed connective tissue diseases (MCTD) and systemic lupus erythematosus (SLE) | AESKULISA® snRNP-C | AESKU.DIAGNOSTICS GMBH & CO. KG | |
| 39 | 04250289500463 | 3104 | AESKULISA U1-70 is a solid phase enzyme immunoassay employing recombinant human AESKULISA U1-70 is a solid phase enzyme immunoassay employing recombinant human 70 kDa protein of the U1-snRNP complex for the quantitative and qualitative detection of antibodies against the 70 kDa U1-RNP in human serum. The assay is a tool in the diagnosis of mixed connective tissue diseases (MCTD) and systemic lupus erythematosus (SLE). | AESKULISA® U1-70 | AESKU.DIAGNOSTICS GMBH & CO. KG | |
| 40 | 04250289500456 | 3103 | AESKULISA ENA-6Pro is a solid phase enzyme immunoassay for the separate semiquan AESKULISA ENA-6Pro is a solid phase enzyme immunoassay for the separate semiquantitative detection of IgG antibodies against six cellular and nuclear antigens in human serum. The wells are coated with recombinant SS-B, SS-A 52 kDa, Scl 70, Jo-1 and highly purified native human snRNP/Sm, Sm and SS-A 60 kDa. The assay is a tool in the differential diagnosis of systemic rheumatic diseases. | AESKULISA® ENA-6Pro | AESKU.DIAGNOSTICS GMBH & CO. KG | |
| 41 | 04250289500425 | 3101 | AESKULISA ANA-8Pro is a solid phase enzyme immunoassay for the separate qualitat AESKULISA ANA-8Pro is a solid phase enzyme immunoassay for the separate qualitative detection of IgG antibodies against eight cellular and nuclear antigens in human serum. The wells are separately coated with recombinant 70 kDa U1 snRNP, SS-B, SS-A 52 kDa, Scl 70, centromere protein B (CenpB), Jo-1 and highly purified native human snRNP/Sm, Sm and SS-A 60 kDa. The assay is a tool in the differential diagnosis of systemic rheumatic diseases. | AESKULISA® ANA-8Pro | AESKU.DIAGNOSTICS GMBH & CO. KG | |
| 42 | 04049016124917 | DL 1590-6401-9 G | EUROLINE ENA Profile 9 Ag (IgG) | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
| 43 | 04049016124900 | DL 1590-1601-9 G | EUROLINE ENA Profile 9 Ag (IgG) | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
| 44 | 04049016084785 | DL 1590-6401-4 G | EUROLINE ENA ProfilePlus 4 (IgG) | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
| 45 | 04049016083139 | DL 1590-1601-4 G | EUROLINE ENA ProfilePlus 4 (IgG) | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
| 46 | 04049016027065 | EA 1611-9601 G | Anti-Centromeres ELISA (IgG) | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
| 47 | 04049016026976 | EA 1590-9601-8 G | ANA Screen ELISA (IgG) | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
| 48 | 04048474035810 | EIA-3581 | EIA-3581 | Anti-Jo-1 ELISA is a test system for the quantitative measurement of class autoa Anti-Jo-1 ELISA is a test system for the quantitative measurement of class autoantibodies against Jo-1 in human serum or plasma. | Anti-Jo-1 ELISA | DRG INSTRUMENTS GESELLSCHAFT MIT BESCHRÄNKTER HAFTUNG |
| 49 | 04048474035780 | EIA-3578 | EIA-3578 | Anti-RNP/Sm ELISA is a test system for the quantitative measurement of IgG class Anti-RNP/Sm ELISA is a test system for the quantitative measurement of IgG class autoantibodies against RNP/Sm in human serum or plasma. | Anti-RNP/Sm ELISA | DRG INSTRUMENTS GESELLSCHAFT MIT BESCHRÄNKTER HAFTUNG |
| 50 | 04048474035773 | EIA-3577 | EIA-3577 | Anti-Sm ELISA is a test system for the quantitative measurement of IgG class aut Anti-Sm ELISA is a test system for the quantitative measurement of IgG class autoantibodies against Sm in human serum or plasma. | Anti-Sm ELISA | DRG INSTRUMENTS GESELLSCHAFT MIT BESCHRÄNKTER HAFTUNG |