| Primary Device ID | 07350049850221 |
| NIH Device Record Key | 8337d3db-7df1-4740-97d8-05647a8abf99 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Phadebact CSF Test |
| Version Model Number | 10-5592-12 |
| Catalog Number | 10-5592-12 |
| Company DUNS | 350472667 |
| Company Name | Mkl Diagnostics AB |
| 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 | true |
| Device Combination Product | false |
| Single Use | false |
| 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 | true |
| Phone | 8002556730 |
| ITechnicalSupport@remel.com |
| Handling 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 | 07350049850221 [Primary] |
| GTJ | Antisera, All Groups, N. Meningitidis |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-11-17 |
| 07350049850122 - Phadebact Pneumococcus Test | 2018-09-20 |
| 07350049850160 - Phadebact Streptococcus Test | 2018-09-20 |
| 07350049850177 - Phadebact Strep A Test | 2018-09-20 |
| 07350049850184 - Phadebact Strep B Test | 2018-09-20 |
| 07350049850191 - Phadebact Strep D Test | 2018-09-20 |
| 07350049850207 - Phadebact Strep F Test | 2018-09-20 |
| 07350049850214 - Phadebact Strep Positive Controls | 2018-09-20 |
| 07350049850238 - Phadebact CSF Positive Controls | 2018-09-20 |