ichroma Reader FPRR001

GUDID 08806133010099

C-reactive protein (CRP) IVD, kit, fluorescent immunoassay

Primary Device ID	08806133010099
NIH Device Record Key	500ac4fe-179e-484d-b8b0-fd17f7615191
Commercial Distribution Status	In Commercial Distribution
Brand Name	ichroma Reader
Version Model Number	FPRR001
Catalog Number	FPRR001
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	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	false
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

Device Issuing Agency	Device ID
GS1	08806133010099 [Primary]

DCN	System, Test, C-Reactive Protein

Steralize Prior To Use	false
Device Is Sterile	false

08806133080849 - Swab-N-Go Home Test COVID-19 Ag	2023-10-18
08806133010068 - AFIAS-50	2022-09-16
08806133010099 - ichroma Reader	2022-06-10
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