IMMCO DIAGNOSTICS 1103-120

GUDID 00845714002120

Hep-2 Cells -Anti-Nuclear Antibody IFA Kit

IMMCO DIAGNOSTICS, INC.

Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay
Primary Device ID00845714002120
NIH Device Record Key2b522bf3-26d5-4801-b0ae-d82d849adde9
Commercial Distribution Discontinuation2017-07-31
Commercial Distribution StatusNot in Commercial Distribution
Brand NameIMMCO DIAGNOSTICS
Version Model Number1103-120
Catalog Number1103-120
Company DUNS079935300
Company NameIMMCO DIAGNOSTICS, 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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-537-8378
EmailINFO@IMMCO.COM

Device Dimensions

Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100845714002120 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LKJAntinuclear Antibody, Antigen, Control

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-21

On-Brand Devices [IMMCO DIAGNOSTICS]

00845714004391Anti-neutrophil cytoplasmic Antibody (ANCA) IFA Kit
00845714004384Anti-neutrophil cytoplasmic Antibody (ANCA) IFA Kit
00845714004353Serum Diluent
00845714004339Buffer Diluent
00845714004322Buffer Diluent
00845714004315Serum Diluent
00845714004308Phosphate Buffered Saline
00845714004247WASH BUFFER
00845714004193Coverslips
00845714004179Mounting Medium
00845714004162Mounting Medium
00845714004001cANCA Positive Control
00845714003974ARA Positive Control
00845714003967EMA (IgG) Positive Control
00845714003943EMA Positive Control
00845714003851pANCA Positive Control
00845714003776cANCA Slide ethanol fixed
00845714003769cANCA Slide
00845714003752cANCA Slide
00845714003714Pemphigold Positive
00845714003707Pemphigus Foliaceus Control
00845714003677nDNA Positive Control
00845714003660Pemphigus Vulgaris Positive Control
00845714003653Rat Kidney Slide
00845714003646Primate Smooth Muscle Slide
00845714003608Primate Esophagus (Distal) Slide
00845714003592Primate Esophagus (Distal) Slide
00845714003585Primate Esophagus Slide
00845714003578Primate Esophagus (Distal) Slide
00845714003561Primate Esophagus Slide
00845714003554Primate/Guinea Pig Esophagus Slide
00845714003547Mouse Kidney/Stomach/Liver Slide
00845714003530Hep-2 Cells Slide
00845714003479IgG FITC Conjugate
00845714003462Coverslips
00845714003448Mouse Kidney Slide
00845714003387pANCA Slide
00845714003370c+p ANCA COMBI Slide
00845714003363Hep-2/Mouse Kidney/Stomach Slide
00845714003332Hep-2/Mouse Kidney Slide
00845714003318Negative Control
00845714003257Intercellular Positive
00845714003240Crithidia Luciliae Slide
00845714003233Hep-2 Cells Slide
00845714003226Hep-2 Cells Slide
00845714003223Hep-2 Cells Slide
00845714003066IgA/IgG FITC Conjugate w/EB
00845714003059IgA/IgG FITC Conjugate
00845714003035IgA FITC Conjugate
00845714003011IgG FITC Conjugate

Trademark Results [IMMCO DIAGNOSTICS]

Mark Image

Registration | Serial
Company
Trademark
Application Date
IMMCO DIAGNOSTICS
IMMCO DIAGNOSTICS
85314467 4117553 Live/Registered
IMMCO Diagnostics, Inc.
2011-05-06

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