FDA.reportPublic FDA data

BioPlex 2200

Primary DI
00847865000420
Brand
BioPlex 2200
Company
BIO-RAD LABORATORIES, INC.
Model
6631630
Catalog number
6631630
Device description
ToRC IgG Control Set
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
JJYMulti-analyte controls, all kinds (assayed)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJYMulti-Analyte Controls, All Kinds (Assayed)Clinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847865000420PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847865000420008478650004208478650004200847865000420

GMDN Terms#

Term, Definition table
TermDefinition
Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to cytomegalovirus (CMV) in a clinical specimen.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Total Volume1.5Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03610522231072Liquichek12015644120156442024-05-24
03610522231089Liquichek12015645120156452024-05-24
03610522231096Liquichek12015646120156462024-05-24
03610522231102Liquichek12015647120156472024-05-24
03610522231119Liquichek12015648120156482024-05-24
03610522231461InteliQ12015705120157052024-05-24
03610522231478InteliQ12015706120157062024-05-24
03610522231485InteliQ12015707120157072024-05-24
03610522231492InteliQ12015708120157082024-05-24
03610522231508InteliQ12015709120157092024-05-24
03610522354658Liquichek12019576120195762024-05-24
03610522354665InteliQ12019558120195582024-05-24
00847661004080Quest Diagnostics9559552023-10-09
03610520540916Quest Diagnostics9309302023-10-09
03610520540923Quest Diagnostics9359352023-10-09
03610520540930Quest Diagnostics9459452023-10-09
03610521168942Geenius72480724802023-07-28
03610522162239Geenius12012482120124822023-07-28
03610522162260Geenius12012484120124842023-07-28
03610522168064Geenius12012851120128512023-07-28

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Primary DI, Brand, Company table
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05391523442572Multichem AECTECHNO-PATH MANUFACTURING LIMITEDJJY2026-03-23
05391523442589Multichem AECTECHNO-PATH MANUFACTURING LIMITEDJJY2026-03-23
05391523442596Multichem AECTECHNO-PATH MANUFACTURING LIMITEDJJY2026-03-23
05391523442602Multichem IA SET ATECHNO-PATH MANUFACTURING LIMITEDJJY2026-03-23
05391523442619Multichem IA SET ATECHNO-PATH MANUFACTURING LIMITEDJJY2026-03-23
05391523442626Multichem IA SET ATECHNO-PATH MANUFACTURING LIMITEDJJY2026-03-23
03701700819400ELITROL IVITALSCIENTIFICJJY2026-03-04
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05430003908532LaCARLacar MDX TechnologiesJJY2026-01-15
05430003908549LaCARLacar MDX TechnologiesJJY2026-01-15
05430003908556LaCARLacar MDX TechnologiesJJY2026-01-15
05430003908563SEEKER®Lacar MDX TechnologiesJJY2026-01-15
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