| Primary Device ID | 54119670013782 |
| NIH Device Record Key | 1c5366b8-c8b8-41f6-b9dc-d73b800b27c2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SpermMar IgG Positive Control |
| Version Model Number | SPMG_P |
| Company DUNS | 373904101 |
| Company Name | Fertipro NV |
| 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 | 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 | false |
| Phone | +3250791805 |
| info@fertipro.com | |
| Phone | +3250791805 |
| info@fertipro.com |
| 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 | 54119670013782 [Primary] |
| KTO | Reagent, Immunoassay, Igg |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-09-24 |
| Device Publish Date | 2018-08-22 |
| 54119670013782 | SpermMar IgG Positive Control: Control for use with the Indirect Test for Determination of Sperm |
| 05411967001378 | SpermMar IgG Positive Control: Control for use with the Indirect Test for Determination of Sperm |