FDA.report

BioPlex 2200

Primary DI
00847865000130
Brand
BioPlex 2200
Company
BIO-RAD LABORATORIES, INC.
Model
6631220
Catalog number
6631220
Device description
EBV IgG Calibrator Lot Data
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
JIXCALIBRATOR, MULTI-ANALYTE MIXTURE

Product Code Classifications

CodeDeviceSpecialtyClass
JIXCalibrator, Multi-Analyte MixtureClinical Chemistry2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00847865000130PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00847865000130008478650001308478650001300847865000130

GMDN Terms

TermDefinition
Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to Epstein-Barr virus (EBV) in a clinical specimen.

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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