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RELISA® ENA Multiparameter Antibody Screening Test

Primary DI
M7497096091
Brand
RELISA® ENA Multiparameter Antibody Screening Test
Company
IMMUNO CONCEPTS INC
Model
7096-09
Catalog number
7096-09
Device description
RELISA® ENA Combination Test System - 96 Wells
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M7497096091PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Multiple extractable nuclear antigen auto-antibody (anti-ENA) screening IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative screening for one or multiple auto-antibodies to extractable nuclear antigens (anti-ENA) in a clinical specimen, using an enzyme immunoassay (EIA) method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
038271904
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M7491216001R1Histofluor® Primate Esophagus Autoantibody Fluorescent Test System 12160-01R12160-01R2026-02-05
M7491208002T1Histofluor® Rodent LKS Fluorescent Antibody Test System 12080-02 (T)12080-02 (T)2025-06-03
M7491208003T1Histofluor® Rodent LKS Fluorescent Antibody Test System 12080-03 (T)12080-03 (T)2025-06-03
M7492075B11HEp-2000® IgG Fluorescent ANA-Ro Test System2075B (1)2075B (1)2025-06-03
M7492280CSROT1HEp-2000® IgG Fluorescent ANA-Ro Test System2280CS-Ro (T)2280CS-Ro (T)2025-06-03
M7492280CST1Fluorescent ANA Test System2280CS (T)2280CS (T)2025-06-03
M7498216ROT1HEp-2000® IgG Fluorescent ANA-Ro Test System8216-Ro (T)8216-Ro (T)2025-06-03
M7498262ROT1HEp-2000® Fluorescent ANA-Ro Test System8262-Ro (T)8262-Ro (T)2025-06-03
M7498264ROT1HEp-2000® IgG Fluorescent ANA-Ro Test System8264-Ro (T)8264-Ro (T)2025-06-03
M7498400RO1HEp-2000® Fluorescent ANA-Ro Test System8400-Ro8400-Ro2016-09-24
M7490083231Fluorescent ANA Test System832383232023-10-06
M7498318RO1HEp-2000® IgG Fluorescent ANA-Ro Test System8318-Ro8318-Ro2017-06-07
M7498262RO1HEp-2000® Fluorescent ANA-Ro Test System8262-Ro8262-Ro2016-09-24
M7492040CS1Fluorescent ANA Test System2040CS2040CS2024-02-27
M7492075B1HEp-2000® IgG Fluorescent ANA-Ro Test System2075B (1)2075B (1)2024-02-27
M7490831121Fluorescent ANA Test System8311.28311.22022-12-06
M7498303RO1HEp-2000® IgG Fluorescent ANA-Ro Test System8303-Ro8303-Ro2022-08-09
M74902140B1HEp-2 Fluorescent w/cs ANA Test System2140B2140B2021-04-28
M74902280B1HEp-2 Fluorescent w/cs ANA Test System2280B2280B2021-04-28
M7492280BRO1HEp-2000® IgG Fluorescent w/cs ANA-Ro Test System2280B-Ro2280B-Ro2021-04-28