Bartels® B1029-81

GUDID 05391516745871

Bartels® CMV Fluorescent Antibody Test

TRINITY BIOTECH PUBLIC LIMITED COMPANY

Cytomegalovirus (CMV) antigen IVD, kit, fluorescent immunoassay
Primary Device ID05391516745871
NIH Device Record Key38809790-081c-4a93-bc73-d6d6d0b48b43
Commercial Distribution Discontinuation2019-01-01
Commercial Distribution StatusNot in Commercial Distribution
Brand NameBartels®
Version Model NumberB1029-81
Catalog NumberB1029-81
Company DUNS988298840
Company NameTRINITY BIOTECH PUBLIC LIMITED COMPANY
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+35312769800
EmailInfectiousdisease.techsupport@trinitybiotech.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
GS105391516745871 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LINAntisera, Conjugated Fluorescent, Cytomegalovirus

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-05-10
Device Publish Date2016-09-23

On-Brand Devices [Bartels®]

05391516745949Bartels® Herpes Simplex Virus Antigen Control Slides
05391516745932Bartels® HSV Fluorescent Monoclonal Antibody Test
05391516745925Bartels® Anti-HSV mouse monoclonal FITC conjugate
05391516745918Bartels® HSV Fluorescent Monoclonal Antibody Test
05391516745901Bartels® CMV Immediate Early Antigen Kit
05391516745888Bartels® Cytomegalovirus Antigen Control Slides
05391516745871Bartels® CMV Fluorescent Antibody Test
05391516745864Bartels® HSV Type 1 and Type 2 Antigen Control Slides
05391516745826Bartels® HSV Type Specific Fluorescent Monoclonal Antibody Test
05391516745161Bartels® Cytomegalovirus Fluorescent Antibody Reagent

Trademark Results [Bartels]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BARTELS
BARTELS
78298443 2956979 Dead/Cancelled
Lion Brewery, Inc., The
2003-09-10
BARTELS
BARTELS
77683372 3721302 Live/Registered
Bartels USA, Inc.
2009-03-04
BARTELS
BARTELS
76341437 2697351 Live/Registered
Trinity Biotech Manufacturing Limited
2001-11-16
BARTELS
BARTELS
71132462 0141863 Dead/Cancelled
Bartels Brewing Company, The
1920-05-15

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