ichroma Reader FPRR001

GUDID 08806133010099

Boditech Med Inc.

C-reactive protein (CRP) IVD, kit, fluorescent immunoassay C-reactive protein (CRP) IVD, kit, fluorescent immunoassay C-reactive protein (CRP) IVD, kit, fluorescent immunoassay C-reactive protein (CRP) IVD, kit, fluorescent immunoassay C-reactive protein (CRP) IVD, kit, fluorescent immunoassay C-reactive protein (CRP) IVD, kit, fluorescent immunoassay
Primary Device ID08806133010099
NIH Device Record Key500ac4fe-179e-484d-b8b0-fd17f7615191
Commercial Distribution StatusIn Commercial Distribution
Brand Nameichroma Reader
Version Model NumberFPRR001
Catalog NumberFPRR001
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 Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS108806133010099 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DCNSystem, Test, C-Reactive Protein

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2022-06-10
Device Publish Date2017-10-26

Devices Manufactured by Boditech Med Inc.

08806133080849 - Swab-N-Go Home Test COVID-19 Ag2023-10-18
08806133010068 - AFIAS-502022-09-16
08806133010099 - ichroma Reader2022-06-10
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.