HEp-2000® IgG Fluorescent ANA-Ro Test System 2140B-Ro

GUDID M7492140BRO1

HEp-2000® IgG FA w/cs ANA-Ro Test System - 140 Tests

IMMUNO CONCEPTS INC

Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay
Primary Device IDM7492140BRO1
NIH Device Record Keyacdabaac-aeb3-4c65-8a0e-29e68fe683a5
Commercial Distribution StatusIn Commercial Distribution
Brand NameHEp-2000® IgG Fluorescent ANA-Ro Test System
Version Model Number2140B-Ro
Catalog Number2140B-Ro
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
HIBCCM7492140BRO1 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-04
Device Publish Date2021-04-26

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Trademark Results [HEp-2000]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HEP-2000
HEP-2000
74481918 2029088 Live/Registered
IMMUNO CONCEPTS N.A. LTD.
1994-01-18

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