Immco Diagnostics, Inc. 2150

GUDID 00845714003219

HeP-2 Cells Slide

IMMCO DIAGNOSTICS, INC.

Multiple antinuclear antibody (ANA) screening IVD, reagent
Primary Device ID00845714003219
NIH Device Record Key5e19aaba-48b0-4e6f-ab67-dce7629288e6
Commercial Distribution StatusIn Commercial Distribution
Brand NameImmco Diagnostics, Inc.
Version Model Number2150
Catalog Number2150
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 Kitfalse
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 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
GS100845714003219 [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 Date2017-02-02

On-Brand Devices [Immco Diagnostics, Inc.]

00845714004841Lyme B. burgdorferi (IgM) Marstripe Test
00845714004834Lyme B. burgdorferi (IgM) Marstripe Test
00845714004810Lyme B. burgdorferi (IgM) Marstripe Test
00845714004728Lyme B. burgdorferi (IgG) Marstripe Test
00845714004711Lyme B. burgdorferi (IgG) Marstripe Test
00845714004704Lyme B. burgdorferi (IgG) Marstripe Test
00845714004117HEp-2 cells / DFS-70 KO Slide
00845714003219HeP-2 Cells Slide
00845714002670ImmuLisa anti-gliadin IgA ELISA
00845714002663ImmuLisa anti-gliadin IgG ELISA
00845714002526AMA-M2 Screen ELISA
00845714002502AMA-M2 IgG ELISA
00845714002458B2GP1 Screen ELISA
00845714002441B2GP1 IgM ELISA
00845714002434B2GP1 IgG ELISA
00845714002069ImmuGlo HEp-2 ELITE IFA
00845714002052ImmuGlo HEp-2 ELITE IFA

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