Primary Device ID | 00813545026486 |
NIH Device Record Key | 8c1d5173-fcb4-4585-ba89-dc42e0a526f8 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Toxocara Antibody 96 Tests |
Version Model Number | TC-96 |
Catalog Number | TC-96 |
Company DUNS | 155424708 |
Company Name | SCIMEDX CORPORATION |
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 | true |
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 | 18002215598 |
service@scimedx.com | |
Phone | 18002215598 |
service@scimedx.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00813545026486 [Primary] |
GMO | Antigen, Latex Agglutination, Entamoeba Histolytica & Rel. Spp. |
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 | 2016-09-21 |
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