FDA.reportPublic FDA data

ELISA Sm/RNP Smart Kit Test System

Primary DI
00845533001106
Brand
ELISA Sm/RNP Smart Kit Test System
Company
ZEUS SCIENTIFIC, INC.
Model
SM2Z2841G
Catalog number
SM2Z2841G
Device description
The ZEUS ELISA Sm/RNP Test System is a semi-quantitative immunoassay for the detection of IgG antibodies to Sm/RNP in human sera. When performed according to these instructions, the results of this assay may aid in the diagnosis and treatment of autoimmune connective tissue disorders. This device is for In Vitro diagnostic use.
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00845533001106PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845533001106008455330011068455330011060845533001106

GMDN Terms#

Term, Definition table
TermDefinition
Sm/RNP antibody IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to Sm/RNP antigen complex (anti-Sm/RNP) in a clinical specimen, using an enzyme immunoassay (EIA) method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080953946
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

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