FDA.report

BioPlex 2200

Primary DI
00847865000161
Brand
BioPlex 2200
Company
BIO-RAD LABORATORIES, INC.
Model
6651250
Catalog number
6651250
Device description
EBV IgG Reagent Pack
Published
2016-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
LSEEPSTEIN-BARR VIRUS, OTHER

Product Code Classifications

CodeDeviceSpecialtyClass
LSEEpstein-Barr Virus, OtherMicrobiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00847865000161PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00847865000161008478650001618478650001610847865000161

GMDN Terms

TermDefinition
Epstein-Barr virus nuclear antigen (EBNA) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to the Epstein-Barr virus nuclear antigen (EBNA) of Epstein-Barr virus (EBV) in a clinical specimen, using a fluorescent immunoassay method. The assay is designed to detect infection with Epstein-Barr virus (EBV), the virus associated with infectious mononucleosis and glandular fever.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)224-6723TechSupport.USSD@bio-rad.com

Regulatory Flags

DUNS number
884513334
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
true
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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