FDA.reportPublic FDA data

MONOLISA

Primary DI
00847865012379
Brand
MONOLISA
Company
BIO-RAD
Model
72495
Catalog number
72495
Device description
MONOLISA Anti-HAV IgM EIA
Published
2016-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LOLHepatitis A Test (Antibody And Igm Antibody)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LOLHepatitis A Test (Antibody And Igm Antibody)Microbiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K092353000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092353000MONOLISA ANTI-HAV IGM EIABio-Rad Laboratories, Inc.2009-10-29LOL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847865012379PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847865012379008478650123798478650123790847865012379

GMDN Terms#

Term, Definition table
TermDefinition
Hepatitis A virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin M (IgM) antibodies to the Hepatitis A virus in a clinical specimen, using an enzyme immunoassay (EIA) method.

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-redmond@bio-rad.com

Regulatory Flags#

DUNS number
269902602
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03610522220526Platelia12015253120152532023-07-03
03610520002933Select63747637472016-08-16
03610520007860PLATELIA25296252962016-08-16
03610520007877PLATELIA25297252972016-08-16
03610522220519Platelia12015289120152892023-07-03
03610520010785GEENIUS92465924652023-02-03
03610520013328EVOLIS89601896012023-02-03
03610520013571PR 410091587915872023-02-03
03610520014103BIO-RAD87530875302023-02-03
03610522189380Platelia12014064120140642023-01-08
03610520002940Select63748637482023-01-05
03610520034309Select63740637402023-01-05
03610520000953Pastorex56353563532022-12-22
03610520000960Pastorex56356563562022-12-22
03610520002490Platelia62786627862022-12-22
03610520002902Select63726637262022-12-22
03610520002919Select63727637272022-12-22
03610520002971Select63751637512016-08-16
03610520007853PLATELIA26211262112016-08-16
03610520013847Geenius 72461724612015-01-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15099590806446Access anti-HAV IgMBeckman Coulter, Inc.LOL2026-04-23
00380740197650AlinityAbbott GmbHLOL2023-11-04
00630414301259Atellica IM aHAVMSiemens Healthcare Diagnostics Inc.LOL2021-01-15
00630414301297Atellica IM aHAVTSiemens Healthcare Diagnostics Inc.LOL2021-01-15
00380740136628AlinityAbbott GmbHLOL2020-12-23
00380740131371AlinityAbbott GmbHLOL2020-11-06
00380740131562AlinityAbbott GmbHLOL2020-01-06
00380740131579AlinityAbbott GmbHLOL2020-01-06
00380740136611AlinityAbbott GmbHLOL2020-01-06
07613336129715Elecsys Anti-HAV IIRoche Diagnostics GmbHLOL2019-09-30
07613336129722Elecsys Anti-HAV IIRoche Diagnostics GmbHLOL2019-09-30
00630414597737Atellica IM aHAVMSiemens Healthcare Diagnostics Inc.LOL2017-12-27
00630414597744Atellica IM aHAVM QCSiemens Healthcare Diagnostics Inc.LOL2017-12-27
00630414597775Atellica IM aHAVT QCSiemens Healthcare Diagnostics Inc.LOL2017-12-27
00630414597768Atellica IM aHAVTSiemens Healthcare Diagnostics Inc.LOL2017-12-22
04015630939855Elecsys Anti-HAV IgMRoche Diagnostics GmbHLOL2017-09-07
04015630939916Elecsys Anti-HAVRoche Diagnostics GmbHLOL2017-06-20
08056771100199LIAISON® anti-HAVDIASORIN SPALOL2016-09-24
08056771100205LIAISON® Control anti-HAVDIASORIN SPALOL2016-09-24
00630414479996ADVIA Centaur® HAV IgMSiemens Healthcare Diagnostics Inc.LOL2016-09-24
00630414480008ADVIA Centaur® HAV IgM QCSiemens Healthcare Diagnostics Inc.LOL2016-09-24
00630414481876ADVIA Centaur® aHAVTSiemens Healthcare Diagnostics Inc.LOL2016-09-24
00630414481883ADVIA Centaur® Systems QC aHAVTSiemens Healthcare Diagnostics Inc.LOL2016-09-24
00630414498461ADVIA Centaur® aHAVTSiemens Healthcare Diagnostics Inc.LOL2016-09-24
00630414509259ADVIA Centaur® aHAVT QCSiemens Healthcare Diagnostics Inc.LOL2016-09-24
04015630938841Elecsys AntiHAV AssayRoche Diagnostics GmbHLOL2016-09-20
04015630938858Elecsys AntiHAV IgMRoche Diagnostics GmbHLOL2016-09-20
00847865012362MONOLISABIO-RADLOL2016-09-12
00380740011079ARCHITECTAbbott GmbHLOL2016-09-09
00380740011086ARCHITECTAbbott GmbHLOL2016-09-09