FDA.reportPublic FDA data

ELISA M. pneumoniae IgM Smart Kit Test System

Primary DI
00845533000949
Brand
ELISA M. pneumoniae IgM Smart Kit Test System
Company
ZEUS SCIENTIFIC, INC.
Model
SM3Z17601M
Catalog number
SM3Z17601M
Device description
The ZEUS ELISA Mycoplasma pneumoniae IgM Test System provides a means for the qualitative detection of IgM antibodies to Mycoplasma pneumoniae in human sera. When performed according to these instructions, the results of this test may aid in the diagnosis of M. pneumoniae infections in the adult population. This assay is for In Vitro diagnostic use only.
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
00845533000949PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845533000949008455330009498455330009490845533000949

GMDN Terms#

Term, Definition table
TermDefinition
Mycoplasma pneumoniae immunoglobulin M (IgM) 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 immunoglobulin M (IgM) antibodies to Mycoplasma pneumoniae bacteria 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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