Primary Device ID | 08806133010068 |
NIH Device Record Key | a8578f5c-e7de-425f-85e9-9819b87ba232 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | AFIAS-50 |
Version Model Number | FPRR022 |
Catalog Number | FPRR022 |
Company DUNS | 689062203 |
Company Name | Boditech Med Inc. |
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 | false |
Lot Batch | false |
Serial Number | true |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | 732-9180770 |
ageffon@immunostics.com | |
Phone | 732-9180770 |
ageffon@immunostics.com | |
Phone | 732-9180770 |
ageffon@immunostics.com | |
Phone | 732-9180770 |
ageffon@immunostics.com | |
Phone | 732-9180770 |
ageffon@immunostics.com | |
Phone | 732-9180770 |
ageffon@immunostics.com | |
Phone | 732-9180770 |
ageffon@immunostics.com | |
Phone | 732-9180770 |
ageffon@immunostics.com | |
Phone | 732-9180770 |
ageffon@immunostics.com | |
Phone | 732-9180770 |
ageffon@immunostics.com | |
Phone | 732-9180770 |
ageffon@immunostics.com | |
Phone | 732-9180770 |
ageffon@immunostics.com | |
Phone | 732-9180770 |
ageffon@immunostics.com | |
Phone | 732-9180770 |
ageffon@immunostics.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 08806133010068 [Primary] |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2022-09-16 |
Device Publish Date | 2017-10-19 |
08806133080849 - Swab-N-Go Home Test COVID-19 Ag | 2023-10-18 |
08806133010068 - AFIAS-50 | 2022-09-16 |
08806133010068 - AFIAS-50 | 2022-09-16 |
08806133010099 - ichroma Reader | 2022-06-10 |
08806133010136 - ALFIS-3 | 2021-12-14 FLUOROMETER FOR CLINICAL USE |
08806133005262 - AFIAS TSH-SP | 2020-06-17 AFIAS TSH-SP, for use in conjunction with the AFIAS-6/SP Analyzer, is an immunofluorometric test systerm for in vitro diagnostic |
08806133005279 - AFIAS TSH-VB | 2020-06-17 AFIAS TSH-VB, for use in conjunction with the AFIAS-6/VB Analyzer, is an immunofluorometric test systerm intended for in vitro d |
08806679001520 - ichroma™ CRP | 2020-06-17 |
08806679002718 - ichroma™ iFOB | 2020-06-17 |