Primary Device ID | 00613745000169 |
NIH Device Record Key | 725f9bb7-36bb-4c92-b473-a38911768b00 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ImmunoDOT Leptospira IgM |
Version Model Number | 800-4032 |
Catalog Number | 4032 |
Company DUNS | 940425333 |
Company Name | Genbio |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
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 | 858-592-9300 |
support@genbio.com | |
Phone | 858-592-9300 |
support@genbio.com | |
Phone | 858-592-9300 |
support@genbio.com |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
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 | 00613745000169 [Primary] |
GRY | Antigens, All, Leptospira Spp. |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2016-09-24 |
00613745000169 | The GenBio IgM ImmunoDOT Leptospira test is a qualitative enzyme immunoassay that specifically d |
00613745000152 | The GenBio IgM ImmunoDOT Leptospira test is a qualitative enzyme immunoassay that specifically d |
00613745000046 | The GenBio IgM ImmunoDOT Leptospira test is a qualitative enzyme immunoassay that specifically d |