| Primary Device ID | 54119670000294 |
| NIH Device Record Key | 1a3ed3cf-04e2-4658-8b50-fc92a554b8a1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SpermMar Test IgA - single kit |
| Version Model Number | SPMA_S |
| 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 | 54119670000294 [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 |
| 54119670000294 | SpermMar Test IgA is a qualitative beads test for detection of sperm antibodies of the IgA class |
| 05411967002566 | SpermMar Test IgA is a qualitative beads test for detection of sperm antibodies of the IgA class |