Histofluor® IgG Fluorescent Antibody Test System 12009-10 (1)

GUDID M74912009101

Histofluor® IgG Fluorescent Antibody Reagent 1 x 9ml.

IMMUNO CONCEPTS INC

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Primary Device IDM74912009101
NIH Device Record Key9589aa63-860a-49d0-8de1-cb7d1e0f92d0
Commercial Distribution StatusIn Commercial Distribution
Brand NameHistofluor® IgG Fluorescent Antibody Test System
Version Model Number12009-10 (1)
Catalog Number12009-10 (1)
Company DUNS038271904
Company NameIMMUNO CONCEPTS 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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM74912009101 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-03-06
Device Publish Date2024-02-27

Devices Manufactured by IMMUNO CONCEPTS INC

M74912009101 - Histofluor® IgG Fluorescent Antibody Test System 2024-03-06Histofluor® IgG Fluorescent Antibody Reagent 1 x 9ml.
M74912009101 - Histofluor® IgG Fluorescent Antibody Test System 2024-03-06 Histofluor® IgG Fluorescent Antibody Reagent 1 x 9ml.
M7492040CS1 - Fluorescent ANA Test System2024-03-06 ANA Fluorescent w/cs Test System - 70 Tests
M7492075B1 - HEp-2000® IgG Fluorescent ANA-Ro Test System2024-03-06 IgG (Gamma) Fluorescent Antibody Reagent w/counterstain- 1 x 23 ml
M749120210111 - Histofluor® IgA Fluorescent Antibody Test System 2023-02-27 Histofluor® EMA Positive Control 1 x 1.0 ml
M7490831121 - Fluorescent ANA Test System2022-12-14 Custom - ANA Fluorescent w/cs BP - 7000 Tests
M74900IN2201 - Image Navigator®2022-09-16 Automated microscope system for immunofluorescent determination of autoantibodies.
M7498303RO1 - HEp-2000® IgG Fluorescent ANA-Ro Test System2022-08-17 Custom - HEp-2000® IgG FA w/cs ANA-Ro Bulk Pack - 1050 Tests
M749120090111 - Histofluor® IgA Fluorescent Antibody Test System 2022-04-20 Histofluor® IgA Fluorescent Antibody Reagent 1 x 9ml.

Trademark Results [Histofluor]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HISTOFLUOR
HISTOFLUOR
87723026 5521476 Live/Registered
Immuno Concepts N.A., Ltd.
2017-12-15
HISTOFLUOR
HISTOFLUOR
87723001 5510222 Live/Registered
Immuno Concepts N.A., Ltd.
2017-12-15

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