| Primary Device ID | 00847865013130 |
| NIH Device Record Key | b4e95c40-7468-414f-8423-be6182b73dbb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MONOLISA™ |
| Version Model Number | 26199 |
| Catalog Number | 26199 |
| Company DUNS | 844766394 |
| Company Name | Bio-RAD Laboratories, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| 00847865013178 | Anti-HBc IgM EIA, Cutoff Calibrator, 1.5 mL |
| 00847865013161 | Anti-HBc IgM EIA, Conjugate, Lyophilized, 7.5 mL |
| 00847865013154 | Anti-HBc IgM EIA, Negative Control, 0.8 mL |
| 00847865013147 | Anti-HBc IgM EIA, Positive Control,1.6 mL |
| 00847865013130 | Anti-HBc IgM EIA, Specimen Diluent, 30 mL |
| 00847865013123 | Anti-HBc IgM EIA Conjugate Diluent, 30 mL |
| 00847865013116 | Anti-HBc EIA, Negative Control, 0.8 mL |
| 00847865013109 | Anti-HBc EIA, Specimen Diluent, 30 mL |
| 00847865013093 | Anti-HBc EIA, Cutoff Calibrator, 1.5 mL |
| 00847865013086 | Anti-HBc EIA, Positive Control, 0.8 mL |
| 00847865013079 | Anti-HBc EIA, Conjugate Reagent 30 mL |
| 00847865011372 | MONOLISA™ Anti-HBc EIA 192 Tests |
| 00847865011365 | MONOLISA™ Anti-HBc IgM EIA, 192 Tests |
| 00847865002110 | Anti-HBs EIA, Specimen Diluent 10 mL |
| 00847865002103 | Anti-HBs EIA, Conjugate Diluent 15 mL |
| 00847865002097 | Anti-HBs EIA, 10 mIU/mL Calibrator 1.8 mL |
| 00847865002080 | Anti-HBs EIA, Negative Control 1.5 mL |
| 00847865002073 | Anti-HBs EIA, Positive Control 1.5 mL |
| 00847865002066 | Anti-HBs EIA Hepatitis B Surface Antigen (Human) Horeseradish Peroxidase Conjugate |
| 00847865002042 | MONOLISA™ Anti-HBs EIA Calibrator Kit |