Primary Device ID | 54119670013614 |
NIH Device Record Key | c7b0d307-b57b-4936-838e-ab3f9eb0c58a |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | SpermMar IgG Negative Control |
Version Model Number | SPMG_N |
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 | 54119670013614 [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 |
54119670013614 | SpermMar IgG Negative Control: Control for use with the Indirect Test for Determination of Sperm |
05411967001361 | SpermMar IgG Negative Control: Control for use with the Indirect Test for Determination of Sperm |