Primary Device ID | B110ADG31200 |
NIH Device Record Key | 16c5c691-625c-4c93-9645-df93ce4303d9 |
Commercial Distribution Discontinuation | 2017-01-30 |
Commercial Distribution Status | Not in Commercial Distribution |
Brand Name | Adenovirus IgG Control |
Version Model Number | ADG-3120 |
Catalog Number | ADG-3120 |
Company DUNS | 024824641 |
Company Name | Bion Enterprises, Ltd. |
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 | true |
OTC Over-The-Counter | false |
Phone | 847-544-5044 |
bion@mblintl.com | |
Phone | 847-544-5044 |
bion@mblintl.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 |
---|---|
HIBCC | B110ADG31200 [Primary] |
GNY | Antisera, Fluorescent, Adenovirus 1-33 |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2020-03-04 |
Device Publish Date | 2016-09-12 |
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B110AD31120 - Adenovirus Antigen Substrate, 12 wells, For IFA Test System | 2020-03-04 |
B110ADG31200 - Adenovirus IgG Control | 2020-03-04 |
B110ADG31200 - Adenovirus IgG Control | 2020-03-04 |
B110ADN31100 - Adenovirus Negative Control | 2020-03-04 |
B110AN10060 - Antinuclear Antibody HEp-2 Antigen Substrate 6 wells, For IFA Test System | 2020-03-04 |
B110AN10120 - Antinuclear Antibody HEp-2 Antigen Substrate, 12 wells, For IFA Test System | 2020-03-04 |