FDA.reportPublic FDA data

AUTO I.D.® Sm/RNP Autoantibody Test System

Primary DI
M7490600511
Brand
AUTO I.D.® Sm/RNP Autoantibody Test System
Company
IMMUNO CONCEPTS INC
Model
6005 (1)
Catalog number
6005 (1)
Device description
AUTO I.D.® Optional Control - Scl-70 - 1 x 0.5 ml
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
M7490600511PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Scleroderma-70 antibody (anti-Scl-70) IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of antibodies to scleroderma-70 (anti-Scl-70) in a clinical specimen.

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
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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