| Primary Device ID | 00613745013411 |
| NIH Device Record Key | 859bd0dc-f8b1-423b-a615-693644c7f568 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ImmunoFA Toxoplasma IgM Positive Control |
| Version Model Number | 800-1341 |
| Catalog Number | 1341 |
| Company DUNS | 940425333 |
| Company Name | Genbio |
| 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 | true |
| 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 |
| Phone | 858-592-9300 |
| support@genbio.com | |
| Phone | 858-592-9300 |
| support@genbio.com | |
| Phone | 858-592-9300 |
| support@genbio.com | |
| Phone | 858-592-9300 |
| support@genbio.com | |
| Phone | 858-592-9300 |
| support@genbio.com | |
| Phone | 858-592-9300 |
| support@genbio.com | |
| Phone | 858-592-9300 |
| support@genbio.com | |
| Phone | 858-592-9300 |
| support@genbio.com | |
| Phone | 858-592-9300 |
| support@genbio.com | |
| Phone | 858-592-9300 |
| support@genbio.com | |
| Phone | 858-592-9300 |
| support@genbio.com | |
| Phone | 858-592-9300 |
| support@genbio.com | |
| Phone | 858-592-9300 |
| support@genbio.com | |
| Phone | 858-592-9300 |
| support@genbio.com | |
| Phone | 858-592-9300 |
| support@genbio.com |
| 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 |
| 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 |
| 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 |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00613745013411 [Primary] |
| GLZ | Antigens, If, Toxoplasma Gondii |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-24 |
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| 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 |
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| 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 |