AFIAS-50 FPRR022

GUDID 08806133010068

Boditech Med Inc.

Specimen processing instrument IVD
Primary Device ID08806133010068
NIH Device Record Keya8578f5c-e7de-425f-85e9-9819b87ba232
Commercial Distribution StatusIn Commercial Distribution
Brand NameAFIAS-50
Version Model NumberFPRR022
Catalog NumberFPRR022
Company DUNS689062203
Company NameBoditech Med Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone732-9180770
Emailageffon@immunostics.com
Phone732-9180770
Emailageffon@immunostics.com
Phone732-9180770
Emailageffon@immunostics.com
Phone732-9180770
Emailageffon@immunostics.com
Phone732-9180770
Emailageffon@immunostics.com
Phone732-9180770
Emailageffon@immunostics.com
Phone732-9180770
Emailageffon@immunostics.com
Phone732-9180770
Emailageffon@immunostics.com
Phone732-9180770
Emailageffon@immunostics.com
Phone732-9180770
Emailageffon@immunostics.com
Phone732-9180770
Emailageffon@immunostics.com
Phone732-9180770
Emailageffon@immunostics.com
Phone732-9180770
Emailageffon@immunostics.com
Phone732-9180770
Emailageffon@immunostics.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108806133010068 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2022-09-16
Device Publish Date2017-10-19

Devices Manufactured by Boditech Med Inc.

08806133080849 - Swab-N-Go Home Test COVID-19 Ag2023-10-18
08806133010068 - AFIAS-502022-09-16
08806133010068 - AFIAS-502022-09-16
08806133010099 - ichroma Reader2022-06-10
08806133010136 - ALFIS-32021-12-14 FLUOROMETER FOR CLINICAL USE
08806133005262 - AFIAS TSH-SP2020-06-17 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-VB2020-06-17 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™ CRP2020-06-17
08806679002718 - ichroma™ iFOB2020-06-17

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.