FITC Quality Control Slide ™ 1900 (1)

GUDID M7490190011

FITC Quality Control Slide

IMMUNO CONCEPTS INC

Optical instrument calibration/verification reference standard IVD
Primary Device IDM7490190011
NIH Device Record Keydc9cf3da-13cd-4013-bf66-f4501c7386c3
Commercial Distribution StatusIn Commercial Distribution
Brand NameFITC Quality Control Slide ™
Version Model Number1900 (1)
Catalog Number1900 (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
HIBCCM7490190011 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-01-20
Device Publish Date2020-01-10

Devices Manufactured by IMMUNO CONCEPTS INC

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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.

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