MERIFLUOR EBV-NA

Primary DI: 00840733101953
Brand: MERIFLUOR EBV-NA
Company: MERIDIAN BIOSCIENCE, INC.
Model: EN100
Catalog number: EN100
Device description: The MERIFLUOR EBV-NA Test is a rapid, sensitive anti-complement immunofluorescence (ACIF) test for the qualitative or quantitative detection of antibodies to the nuclear antigen of Epstein-Barr virus in human serum. The test can provide valuable diagnostic information to facilitate patient management when used in conjunction with other EBV antibody tests.
Published: 2020-10-26
Public version status: Update
Distribution status: Not in Commercial Distribution
MRI safety: Labeling does not contain MRI Safety Information
Rx: true
Single use: true

Contact Domains#

Code, Name table
Code	Name
LLM	Test, Antigen, Nuclear, Epstein-Barr Virus

Code, Device, Specialty table
Code	Device	Specialty	Class
LLM	Test, Antigen, Nuclear, Epstein-Barr Virus	Microbiology	1

Submission, Supplement table
Submission	Supplement
K880043	000

Submission, Supplement, Device table
Submission	Supplement	Device	Applicant	Decision date	Product code
K880043	000	EBV-NA TEST	Gull Laboratories, Inc.	1988-03-24	LLM

Identifier, Type, Agency table
Identifier	Type	Agency	Package quantity	Status
00840733101953	Primary	GS1	0

Source identifier, GTIN-14 normalized, UPC-A table
Source identifier	GTIN-14 normalized	UPC-A	EAN-13
00840733101953	00840733101953	840733101953	0840733101953

Term, Definition table
Term	Definition
Epstein-Barr virus (EBV) antigen IVD, kit, fluorescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from Epstein-Barr virus (EBV) in a clinical specimen, using a fluorescent immunoassay method. The assay is designed to detect infection with Epstein-Barr virus (EBV), the virus associated with infectious mononucleosis and glandular fever.

Type, Low, High table
Type	Low	High	Condition
Storage Environment Temperature	2 Degrees Celsius	8 Degrees Celsius

Method table
Method

Phone, Email table
Phone	Email
1-800-343-3858	MBI-TechService@meridianbioscience.com

Primary DI, Brand, Model table
Primary DI	Brand	Model	Catalog	Published
00840733101595	StatID PRO COVID/Flu A&B Swabs	783110	783110	2026-05-14
00840733101557	statID Pro COVID-19/Flu External Controls	783010		2026-04-10
00840733101564	statID Pro COVID-19/Flu A&B	783025		2026-04-10
00840733101717	PREMIER CAMPY	618096	618096	2020-09-01
00840733101397	Fungal Immunodiffusion Plates - 4 Series	101009	101009	2019-11-21
00840733101403	Fungal Immunodiffusion Plates - 1 Series	101012	101012	2019-11-21
00840733101014	ANA Screen ELISA Test Kit	4884261	4884261	2016-09-23
00840733102585	Hemo-De	801300	801300	2020-12-09
00840733102660	Modified Hemo-De	801600	801600	2020-09-21
00840733102318	Revogene	610210	610210	2020-07-15
00840733102547	EcoStain	801400	801400	2020-12-09
00840733102394	SpinCon	972200	972200	2020-10-26
00840733103285	Revogene Check	610220	610220	2022-06-27
00840733103339	Para-Pak C&S	9006-01	900612	2021-06-18
00840733102011	Para-Pak C&S	900612	900612	2020-12-09
00840733102714	Para-Pak C&S	900612	900612	2020-12-09
00840733102455	Para-Pak Ultra SAF	980212	980212	2020-12-09
00840733102851	Para-Pak Ultra SAF	980212	980212	2020-12-09
00840733101304	MERIFLUOR GullSORB	XX715	XX715	2016-09-23
00840733102899	Para-Pak SAF in Tubs	990160	990160	2020-12-09

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
05391516746571	Bio-Rad Platelia	CLARK LABORATORIES, INC.	LLM	2019-11-07
05391516743570	Trinity Biotech	CLARK LABORATORIES, INC.	LLM	2019-11-05
05391516743587	Trinity Biotech	CLARK LABORATORIES, INC.	LLM	2019-11-05
05391516747097	Trinity Biotech	CLARK LABORATORIES, INC.	LLM	2019-11-05
05391516747103	Trinity Biotech	CLARK LABORATORIES, INC.	LLM	2019-11-05
B110NA51120	EBV Nuclear Antigen (EBNA) Substrate, 12 wells, For ACIF Test System	Bion Enterprises, Ltd.	LLM	2016-09-12
B110NA51400	EBNA Positive Control	Bion Enterprises, Ltd.	LLM	2016-09-12