FDA.report

Access Rubella IgG Calibrators

Primary DI
15099590624880
Brand
Access Rubella IgG Calibrators
Company
Beckman Coulter, Inc.
Model
33435
Catalog number
34435
Device description
The Access Rubella IgG Calibrators are intended to calibrate the Access Rubella IgG assay for the qualitative and quantitative determination of IgG an
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
LFXEnzyme Linked Immunoabsorbent Assay, Rubella

Product Code Classifications

CodeDeviceSpecialtyClass
LFXEnzyme Linked Immunoabsorbent Assay, RubellaMicrobiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
15099590624880PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1509959062488015099590624880

GMDN Terms

TermDefinition
Rubella virus immunoglobulin G (IgG) 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 G (IgG) antibodies to Rubella virus 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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