| Primary Device ID | 05713106813591 |
| NIH Device Record Key | 156fd59b-d44b-48ee-b896-948a3bf77d2e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | E. coli O2 serum high titer, 1 mL |
| Version Model Number | 81359 |
| Catalog Number | 81359 |
| Company DUNS | 305684449 |
| Company Name | Ssi Diagnostica A/S |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| 05713106994627 - Dermatophyte and C. albicans Real Time PCR kit | 2022-12-05 Intended use
The Dermatophyte and C. albicans Real Time PCR Kit is an in vitro diagnostic kit for the quantitative detection of |
| 05713106105573 - ImmuView S. pneumoniae and L. pneumophila urinary antigen test | 2022-11-02 Urinary antigen test |
| 05713106544013 - E. coli H4 serum, 5 mL | 2021-08-19 Rabbit antiserum, Ready to use |
| 05713106544020 - E. coli H5 serum, 5 mL | 2021-08-19 Rabbit antiserum, Ready to use |
| 05713106544044 - E. coli H6 serum, 5 mL | 2021-08-19 Rabbit antiserum, Ready to use |
| 05713106544068 - E. coli H7 serum, 5 mL | 2021-08-19 Rabbit antiserum, Ready to use |
| 05713106544075 - E. coli H8 serum, 5 mL | 2021-08-19 Rabbit antiserum, Ready to use |
| 05713106544099 - E. coli H9 serum, 5 mL | 2021-08-19 Rabbit antiserum, Ready to use |