FDA.report

Access Toxo IgM II Calibrators

Primary DI
15099590624798
Brand
Access Toxo IgM II Calibrators
Company
Beckman Coulter, Inc.
Model
34475
Catalog number
34475
Device description
The Access Toxo IgM II Calibrators are intended for use with the Access Toxo IgM II assay for the qualitative detection of Toxoplasma gondii-specific
Published
2016-09-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
LGDEnzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii

Product Code Classifications

CodeDeviceSpecialtyClass
LGDEnzyme Linked Immunoabsorbent Assay, Toxoplasma GondiiMicrobiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
15099590624798PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1509959062479815099590624798

GMDN Terms

TermDefinition
Toxoplasma gondii 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 the parasitic protozoan Toxoplasma gondii in a clinical specimen, using an enzyme immunoassay (EIA) method.

Sterilization Methods

Method

Regulatory Flags

DUNS number
008254708
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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