Wako IVD assays for clinical chemistry & immunology
FUJIFILM Wako provides in vitro diagnostic assay reagents for quantitative measurement of key biochemical parameters in serum and, where applicable, plasma.
The assay range supports routine and specialized clinical chemistry applications, including fatty acid metabolism, complement activity, lipid profiling, ketone body measurement, and bilirubin determination.
All reagents are designed for use on automated clinical chemistry analyzers in accordance with the manufacturer’s instructions for use.
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Fatty acid metabolism
NEFA-HR(2) Assay
The NEFA-HR(2) Assay is an in vitro diagnostic (IVD) test for the quantitative determination of non-esterified fatty acids (NEFA) in serum.
The assay is based on an enzymatic colorimetric method and is intended for use on automated clinical chemistry analyzers in accordance with the manufacturer’s instructions for use.
- Intended use: Quantitative determination of non-esterified fatty acids (NEFA) in serum (IVD)
- Specimen: Serum
- Method: Enzymatic colorimetric assay
- Color reaction: Violet color formation using MEHA as color agent
- Reagent components required:
- Reagent 1
- Reagent 1a
- Reagent 2
- Reagent 2a
- Standard
- Application: Designed for automated clinical chemistry analyzers, as specified in the instructions for use
- Storage conditions: 2–10 °C
| Article Number | Description | Volume |
| 994-91801 | NEFA-HR(2) R1 Set | R1a: 4 × for 50 mL; R1b: 4 × 50 mL |
| 990-91901 | NEFA-HR(2) R2 Set | R2a: 4 × for 25 mL; R2b: 4 × 25 mL |
| 991-91791 | NEFA Standard | 2 × 10 mL |
Complement activity
Autokit CH50 Assay
The Autokit CH50 Assay is an in vitro diagnostic (IVD) test for the quantitative determination of total complement activity (CH50) in human serum.
The assay is based on a liposome immunoassay (LIA) principle and is designed for automated measurement on clinical chemistry analyzers, in accordance with the manufacturer’s instructions for use.
- Intended use: Quantitative determination of total complement activity (CH50) in human serum (IVD)
- Specimen: Human serum
- Method: Liposome immunoassay (LIA)
- Application: Designed for automated clinical chemistry analyzers as specified in the instructions for use
| Article Number | Description | Volume |
| 993-40601 | Autokit CH50 Set | R1: 2 × 20 mL; R2a: 1 × for 20 mL; R2b: 1 × 20 mL |
| 993-43901 | CH50 Calibrator Set | 5 concentrations × for 0.5 mL |
| 993-44001 | Complement Control Set | 2 concentrations × 10 × for 0.5 mL |
Ketone body analysis
Autokit Total Ketone Bodies Assay
The Autokit Total Ketone Bodies Assay is an in vitro diagnostic (IVD) test for the quantitative determination of total ketone bodies, including acetoacetic acid and 3-hydroxybutyric acid, in serum or plasma.
The assay is based on a cyclic enzymatic reaction system and is intended for use on automated clinical chemistry analyzers in accordance with the manufacturer’s instructions for use.
- Intended use: Quantitative determination of total ketone bodies in serum or plasma (IVD)
- Analytes: Acetoacetic acid and 3-hydroxybutyric acid
- Method: Cyclic enzymatic assay
- Application: Designed for automated clinical chemistry analyzers as specified in the instructions for use
| Article Number | Description | Volume |
| 996-73301 | Autokit Total Ketone Bodies R1 Set | R1a: 2 × for 27 mL; R1b: 2 × 27 mL |
| 992-73401 | Autokit Total Ketone Bodies R2 Set | R2a: 2 × for 9 mL; R2b: 2 × 9 mL |
| 993-73791 | Ketone Body Calibrator 300 | 4 × 5 mL |
Lipid profiling
HDL-C L-Type Assay
The HDL-C L-Type Assay is an in vitro diagnostic (IVD) reagent for the quantitative determination of high-density lipoprotein cholesterol (HDL-C) in serum.
The assay is intended for use on automated clinical chemistry analyzers in accordance with the manufacturer’s instructions for use.
- Intended use: Quantitative determination of HDL-cholesterol (HDL-C) in serum (IVD)
- Specimen: Serum
- Method: Homogeneous enzymatic assay
- Application: Designed for automated clinical chemistry analyzers as specified in the instructions for use
| Article Number | Description | Volume |
| 999-73391 | L-Type HDL-C R1 | 4 × 60 mL |
| 995-73491 | L-Type HDL-C R2 | 4 × 20 mL |
| 993-73291 | HDL-C Calibrator | 4 × for 3 mL |
Ketone body analysis
Autokit 3-HB Assay
The Autokit 3-HB Assay is an in vitro diagnostic (IVD) test for the quantitative determination of 3-hydroxybutyric acid (3-HB) in serum or plasma.
The assay is based on an enzymatic reaction system and is intended for use on automated clinical chemistry analyzers in accordance with the manufacturer’s instructions for use.
- Intended use: Quantitative determination of 3-hydroxybutyric acid (3-HB) in serum or plasma (IVD)
- Analyte: 3-hydroxybutyric acid
- Method: Enzymatic assay
- Application: Designed for automated clinical chemistry analyzers as specified in the instructions for use
| Article Number | Description | Volume |
| 998-73501 | Autokit 3-HB R1 Set | R1a: 2 × for 27 mL; R1b: 2 × 27 mL |
| 994-73601 | Autokit 3-HB R2 Set | R2a: 2 × for 9 mL; R2b: 2 × 9 mL |
| 993-73791 | Ketone Body Calibrator 300 | 4 × 5 mL |
Lipid profiling
LDL-C L-Type Assay
The LDL-C L-Type Assay is an in vitro diagnostic (IVD) reagent for the quantitative determination of low-density lipoprotein cholesterol (LDL-C) in serum and plasma.
The assay uses a homogeneous enzymatic method and is intended for use on automated clinical chemistry analyzers in accordance with the manufacturer’s instructions for use.
| Article Number | Description | Volume |
| 994-24991 | L-Type LDL-C R1 | 4 × 60 mL |
| 994-25091 | L-Type LDL-C R2 | 4 × 20 mL |
| 998-24891 | LDL-C Calibrator | 4 × for 1 mL |
- Intended use: Quantitative determination of low-density lipoprotein cholesterol (LDL-C) in serum and plasma (IVD)
- Specimen: Serum and plasma
- Method: Homogeneous enzymatic assay (selective protection principle)
- Application: Designed for automated clinical chemistry analyzers as specified in the instructions for use
Bilirubin testing
Total Bilirubin L-Type Assay
The Total Bilirubin L-Type Assay is an in vitro diagnostic (IVD) reagent for the quantitative determination of total bilirubin in serum.
The assay is based on a vanadate oxidation method and is supplied as a liquid, stable reagent for use on automated clinical chemistry analyzers in accordance with the manufacturer’s instructions for use.
- Intended use: Quantitative determination of total bilirubin in serum (IVD)
- Specimen: Serum
- Method: Vanadate oxidation
- Reagent format: Liquid, stable reagent
- Application: Designed for automated clinical chemistry analyzers as specified in the instructions for use
| Article Number | Description | Volume |
| 992-24291 | L-Type Total Bilirubin R1 | 4 × 70 mL |
| 998-24391 | L-Type Total Bilirubin R2 | 4 × 18 mL |
| 994-24491 | Bilirubin Calibrator | 4 × for 3 mL |
Bilirubin testing
Direct Bilirubin L-Type Assay
The Direct Bilirubin L-Type Assay is an in vitro diagnostic (IVD) reagent for the quantitative determination of direct bilirubin in serum and plasma.
The assay is based on a vanadate oxidation method and is supplied as a liquid, stable reagent. It is intended for use on automated clinical chemistry analyzers in accordance with the manufacturer’s instructions for use.
- Intended use: Quantitative determination of direct bilirubin in serum and plasma (IVD)
- Specimen: Serum and plasma
- Method: Vanadate oxidation
- Reagent format: Liquid, stable reagent
- Application: Designed for use on automated clinical chemistry analyzers in accordance with the manufacturer’s instructions for use
| Article Number | Description | Volume |
| 990-24091 | L-Type Direct Bilirubin R1 | 4 × 70 mL |
| 996-24191 | L-Type Direct Bilirubin R2 | 4 × 18 mL |
| 994-24491 | Bilirubin Calibrator | 4 × for 3 mL |