FDA.reportPublic FDA data

Fluorescent ANA Test System

Primary DI
M7492013201
Brand
Fluorescent ANA Test System
Company
IMMUNO CONCEPTS INC
Model
2013 (20)
Catalog number
2013 (20)
Device description
ANA 13 Well HEp-2 Slides - 20 Slides
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
M7492013201PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Multiple antinuclear antibody (ANA) 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 antinuclear antibodies (ANA) 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