| Primary Device ID | 54119670013546 |
| NIH Device Record Key | bb9722fb-417d-4526-b79e-715de80e7521 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SpermMar Test IgG - Complete kit |
| Version Model Number | SPMG_C |
| 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 | 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 | 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 | 54119670013546 [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 | 2019-03-04 |
| Device Publish Date | 2019-02-01 |
| 54119670013546 | SpermMar Test IgG is a qualitative Latex Test for detection of Sperm Antibodies. The SpermMar |
| 05411967001354 | SpermMar Test IgG is a qualitative Latex Test for detection of Sperm Antibodies. The SpermMar |