FDA.reportPublic FDA data

VIROCLEAR MuMZ

Primary DI
00847661002666
Brand
VIROCLEAR MuMZ
Company
BIO-RAD LABORATORIES, INC.
Model
00133
Catalog number
00133
Device description
VIROCLEAR MuMZ (An unassayed (human) serology control.)
Published
2020-09-14
Public version status
New
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
OHQMulti-analyte controls unassayed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHQMulti-Analyte Controls UnassayedClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847661002666PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847661002666008476610026668476610026660847661002666

GMDN Terms#

Term, Definition table
TermDefinition
Varicella-zoster virus (VZV) 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 varicella-zoster virus (VZV) in a clinical specimen.

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)854-6737qsd.techservice@bio-rad.com

Regulatory Flags#

DUNS number
051624070
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
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

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00852720008244Birlinn™ CoV2-Flu-RSV Control Panel M509MmqciOHQ2025-12-04
01220000260634NATtrol™ ZEPTOMETRIX CORPORATIONOHQ2025-12-01
70845357044340QC Sets and Panels: Helix Elite™MICROBIOLOGICS INC.OHQ2025-09-08
70845357044395QC Sets and Panels: Helix Elite™MICROBIOLOGICS INC.OHQ2025-09-08
05056850400038Mimix™ Quantitative Multiplex FFPE reference standardREVVITY DISCOVERY LIMITEDOHQ2025-08-15
80845357044422Helix Elite Molecular StandardsMICROBIOLOGICS INC.OHQ2025-08-14
01220000260627NATtrol™ ZEPTOMETRIX CORPORATIONOHQ2025-08-06
04987270235584Lumipulse Infectious Disease ControlsFUJIREBIO INC.OHQ2025-07-31
01220000260481NATtrol™ZEPTOMETRIX CORPORATIONOHQ2025-07-25
08718734962991CueSee® BGEMEurotrol B.V.OHQ2025-07-25
08718734963004CueSee® BGEMEurotrol B.V.OHQ2025-07-25
08718734963011CueSee® BGEMEurotrol B.V.OHQ2025-07-25
08718734963028CueSee® BGEMEurotrol B.V.OHQ2025-07-25
01220000260498NATtrol™ZEPTOMETRIX CORPORATIONOHQ2025-07-23
00850051429578Fort Worth DiagnosticsFort Worth Diagnostics, LLCOHQ2025-06-20
00850051429639Fort Worth DiagnosticsFort Worth Diagnostics, LLCOHQ2025-06-20
00850051429684Fort Worth DiagnosticsFort Worth Diagnostics, LLCOHQ2025-06-20
05056850400007Mimix™ OncoSpan FFPE Reference StandardREVVITY DISCOVERY LIMITEDOHQ2025-06-05
05056850400014Mimix™ OncoSpan gDNA Reference StandardREVVITY DISCOVERY LIMITEDOHQ2025-06-05
05056850400021Mimix™ Myeloid Cancer Panel gDNA Reference StandardREVVITY DISCOVERY LIMITEDOHQ2025-06-05
01220000260542NATtrol™ZEPTOMETRIX CORPORATIONOHQ2025-03-06
08718734962526CueSee VeriSTAT®Eurotrol B.V.OHQ2024-10-29
08718734962618CueSee VeriSTAT®Eurotrol B.V.OHQ2024-10-29
08718734962625CueSee VeriSTAT®Eurotrol B.V.OHQ2024-10-29
08718734962632CueSee VeriSTAT®Eurotrol B.V.OHQ2024-10-29
10845357044324Helix Elite™ Molecular Standards: Inactivated StandardMICROBIOLOGICS INC.OHQ2024-09-04
70845357044364QC Sets and Panels: Helix Elite™MICROBIOLOGICS INC.OHQ2024-09-04
03610522384372Exact DiagnosticsEXACT DIAGNOSTICS, LLCOHQ2024-08-27
03610522384389Exact DiagnosticsEXACT DIAGNOSTICS, LLCOHQ2024-08-27