| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
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| 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 |
| 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 |
| 00613745000039 - IMMUNODOT™ COXIELLA BURNETII (Q FEVER) | 2025-09-09 The ImmunoDOT test is an enzyme immunoassay for the qualitative detection of antibodies to Coxiella burnetii in serum specimens |
| 00613745000015 - IMMUNODOT™ RICKETTSIA CONORII | 2025-09-08 The GenBio ImmunoDOT Rickettsia conorii (Mediterranean Spotted Fever) test is a semi-quantitative enzyme immunoassay for the det |
| 00613745000022 - IMMUNODOT™ Rickettsia Typhi | 2025-09-08 The GenBio R. typhi (murine typhus) test is a semi-quantitative enzyme immunoassay for the detection of IgG and IgM antibodies t |
| 00613745000060 - IMMUNOFLOW™ Mycoplasma pneumoniae IgM Test | 2025-09-08 ImmunoFLOW Mycoplasma pneumoniae IgM Test detects human IgM to the complement-fixing antigen and is intended as an aid in the di |
| 00613745002231 - IMMUNOWELL JCV IgG Test | 2025-09-08The ImmunoWELL JCV IgG Test is intended for the qualitative detection of antibodies to JC Virus in human serum. The assay is intended for use, in conjunction with other clinical data, in multiple sclerosis patients receiving or considering natalizumab therapy, as an aid in risk stratification for progressive multifocal leukoencephalopathy development. The assay is for professional use only.
The assay is not intended for donor screening. The performance of this assay has not been established for use in other immunocompromised patient populations or patients with different disease conditions or undergoing other treatments or in neonates and pediatric patient populations. |
| 00613745002231 - IMMUNOWELL JCV IgG Test | 2025-09-08 The ImmunoWELL JCV IgG Test is intended for the qualitative detection of antibodies to JC Virus in human serum. The assay is int |
| 00613745031200 - ImmunoWELL™ MYCOPLASMA PNEUMONIAE ANTIBODY (IgG) TEST | 2025-09-08 ImmunoWELL Mycoplasma Pneumoniae Antibody (IgG) Test is a semi–quantitative or qualitative determination of IgG antibodies in |
| 00613745031309 - ImmunoWELL™ MYCOPLASMA PNEUMONIAE ANTIBODY (IgM) TEST | 2025-09-08 ImmunoWELL Mycoplasma Pneumoniae Antibody (IgM) Test is a qualitative enzyme immunoassay (EIA) for the detection of specific IgM |
| 00613745000046 - ImmunoDOT Leptospira IgM | 2018-07-06 The GenBio IgM ImmunoDOT Leptospira test is a qualitative enzyme immunoassay that specifically detects IgM antibodies to Leptosp |