FDA.report

BioPlex 2200

Primary DI
00847865002127
Brand
BioPlex 2200
Company
BIO-RAD LABORATORIES, INC.
Model
SW4_V2
Catalog number
6651260E
Device description
Manual & CDs, BioPlex 2200, EBV IgG IFU, SW4_v2
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
false

Related Records

Contact Domains

Product Codes

CodeName
LSEEPSTEIN-BARR VIRUS, OTHER

Product Code Classifications

CodeDeviceSpecialtyClass
LSEEpstein-Barr Virus, OtherMicrobiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00847865002127PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00847865002127008478650021278478650021270847865002127

GMDN Terms

TermDefinition
Epstein-Barr virus (EBV) early antigen (EA) 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 early antigen (EA) 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

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
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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