HEp-2000® IgG Fluorescent ANA-Ro Test System 8244-Ro

GUDID M7498244RO1

Custom - HEp-2000® IgG FA w/cs ANA-Ro BP - 1400 Tests

IMMUNO CONCEPTS INC

Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay
Primary Device IDM7498244RO1
NIH Device Record Key8679291e-4b53-4168-bae2-1355bc15a641
Commercial Distribution StatusIn Commercial Distribution
Brand NameHEp-2000® IgG Fluorescent ANA-Ro Test System
Version Model Number8244-Ro
Catalog Number8244-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
HIBCCM7498244RO1 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-11-13
Device Publish Date2016-09-24

On-Brand Devices [HEp-2000® IgG Fluorescent ANA-Ro Test System]

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M7498298RO1Custom - HEp-2000® IgG FA ANA-Ro Super BP - 4200 Tests
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M7498269RO1Custom - HEp-2000® IgG FA w/cs ANA-Ro Super BP - 4200 Tests
M7498267RO1Custom- HEp-2000® IgG FA w/cs ANA-Ro Bulk Pack - 1400 Tests
M7498238RO1Custom - HEp-2000® IgG FA ANA-Ro w/cs BP - 5400 wells
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M7492672CSRO1HEp-2000® IgG FA w/cs ANA-Ro Test System - 672 Tests
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M7498301RO1Custom - HEp-2000® IgG FA w/cs ANA-Ro Super BP - 6300 Tests
M7498294RO1Custom- HEp-2000® IgG FA w/cs ANA-Ro Bulk Pack - 2100 Tests
M7498291RO1Custom - HEp-2000® IgG FA w/cs ANA-Ro BP - 1400 Tests
M7498283RO1Custom - HEp-2000® IgG FA w/cs ANA-Ro Super BP - 6300 Tests
M7498232RO1Custom - HEp-2000® IgG FA ANA-Ro Super BP - 4200 Tests
M7498198RO1Custom - HEp-2000® IgG ANA-Ro FA -280 wells
M74981931RO1Custom - HEp-2000® IgG FA w/cs ANA-Ro Super BP - 4200 Tests
M7492140GRO1HEp-2000® IgG Fluorescent ANA-Ro Test System - 140 Tests
M7492000CS21RO1HEp-2000® IgG FA w/cs ANA-Ro Bulk Pack - 2100 Tests
M7498202RO1Custom - HEp-2000® IgG FA ANA-Ro BP - 1800 Tests
M7492145GRO1HEp-2000® IgG Fluorescent ANA-Ro Test System - 140 Tests
M7492140GCSRO1HEp-2000® IgG FA w/cs ANA-Ro Test System - 140 Tests
M7498400CSRO1Custom - HEp-2000® IgG FA w/cs ANA-Ro Super BP - 5400 Tests
M7498321RO1Custom - HEp-2000® IgG FA w/cs ANA-Ro BP - 6300 wells
M7498320RO1Custom - HEp-2000® IgG FA w/cs ANA-Ro BP - 6300 wells
M7498319RO1Custom - HEp-2000® IgG FA w/cs ANA-Ro Bulk Pack - 2100 Tests
M7498315RO1Custom - HEp-2000® IgG FA w/cs ANA-Ro BP - 6300 wells
M7498300CSRO1Custom - HEp-2000® IgG FA w/cs ANA-Ro Super BP - 6300 Tests
M7498290RO1Custom - HEp-2000® IgG FA w/cs ANA-Ro Super BP - 4200 Tests
M7498286RO1Custom - HEp-2000® IgG FA ANA-Ro BP - 6300 wells
M7498282RO1Custom - HEp-2000® IgG FA w/cs ANA-Ro BP - 1400 Tests
M7498279RO1Custom - HEp-2000® IgG FA ANA-Ro BP - 1800 Tests
M7498272RO1Custom - HEp-2000® IgG FA ANA-Ro BP - 350 Tests
M74982711RO1Custom - HEp-2000® IgG FA w/cs ANA-Ro BP - 1400 Tests
M7498263RO1Custom - HEp-2000® IgG FA w/cs ANA-Ro BP - 6300 wells
M74982513RO1Custom - HEp-2000® IgG FA w/cs ANA-Ro Super BP - 6300 Tests
M7498244RO1Custom - HEp-2000® IgG FA w/cs ANA-Ro BP - 1400 Tests
M7498209RO1Custom - HEp-2000® IgG FA ANA-Ro Super BP - 4200 Tests
M7492288CSRO1HEp-2000® IgG FA w/cs ANA-Ro Test System - 288 Tests
M7492200CS14RO1HEp-2000® IgG FA w/cs ANA-Ro Test System - 280 Tests
M7492140CSRO1HEp-2000® IgG FA w/cs ANA-Ro Test System - 140 Tests
M7492075CS11ANA IgG Fluorescent Antibody Reagent w/cs - 1 x 23 mls.
M7492004G14RO1HEp-2000® IgG Fluorescent ANA-Ro Bulk Pack - 1400 Tests
M7492000G14RO1HEp-2000® IgG Fluorescent ANA-Ro Bulk Pack - 1400 Tests
M7492000CS14RO1HEp-2000® IgG FA w/cs ANA-Ro Bulk Pack - 1400 Tests

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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