FDA.reportPublic FDA data

Platelia

Primary DI
03610522220519
Brand
Platelia
Company
BIO-RAD
Model
12015289
Catalog number
12015289
Device description
Platelia SARS-CoV-2 Total Ab
Published
2023-07-03
Public version status
New
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
QKOReagent, coronavirus serological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QKOReagent, Coronavirus SerologicalUnknownN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03610522220519PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03610522220519036105222205193610522220519

GMDN Terms#

Term, Definition table
TermDefinition
SARS-CoV-2 total 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 total antibodies to severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2), the causative agent of coronavirus disease (COVID-19), in a clinical specimen, using an enzyme immunoassay (EIA) method.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

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
Premarket exempt
true
Lot or batch
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
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
03610520013854Geenius723392015-01-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06972412619405LyherHangzhou Laihe Biotech Co.,Ltd.QKO2024-11-11
00816870023557SARS-CoV-2 IgA AccuBind ELISA Test System - 96 WellsMONOBIND, INC.QKO2024-09-13
00816870023564SARS-CoV-2 IgA AccuBind ELISA Test System - 192 WellsMONOBIND, INC.QKO2024-09-13
00816870023595SARS-CoV-2 IgG AccuBind ELISA Test System - 96 WellsMONOBIND, INC.QKO2024-09-13
00816870023601SARS-CoV-2 IgG AccuBind ELISA Test System - 192 WellsMONOBIND, INC.QKO2024-09-13
00816870023632SARS-CoV-2 IgM AccuBind ELISA Test System - 96 WellsMONOBIND, INC.QKO2024-09-13
00816870023649SARS-CoV-2 IgM AccuBind ELISA Test System - 192 WellsMONOBIND, INC.QKO2024-09-13
00816870024868SARS-CoV-2 S1-RBD IgG AccuBind ELISA Test System - 96 WellsMONOBIND, INC.QKO2024-09-13
00816870024875SARS-CoV-2 S1-RBD IgG AccuBind ELISA Test System - 192 WellsMONOBIND, INC.QKO2024-09-13
10758750035465VITROSORTHO CLINICAL DIAGNOSTICSQKO2023-11-22
20758750035462VITROSORTHO CLINICAL DIAGNOSTICSQKO2023-11-22
03610522220526PlateliaBIO-RADQKO2023-07-03
B379COVEG1SCoV-2 Detect™ IgG ELISAINBIOS INTERNATIONAL, INCQKO2022-12-08
B379COVEM1SCoV-2 Detect™ IgM ELISAINBIOS INTERNATIONAL, INCQKO2022-12-08
B379COVGRE1SCoV-2 Detect™ IgG Rapid TestINBIOS INTERNATIONAL, INCQKO2022-12-08
B379COVNE1SCoV-2 Detect™ Neutralizing Ab ELISAINBIOS INTERNATIONAL, INCQKO2022-12-08
06973774259803Biohit SARS-CoV-2 IgM/IgG Antibody Test KitBiohit Healthcare (Hefei) Co., Ltd.QKO2022-08-16
16973774250012Biohit SARS-CoV-2 IgM/IgG Antibody Test KitBiohit Healthcare (Hefei) Co., Ltd.QKO2022-08-16
15099590738617Access SARS-CoV-2 IgMBeckman Coulter, Inc.QKO2022-05-04
15099590738624Access SARS-CoV-2 IgM CalibratorBeckman Coulter, Inc.QKO2022-05-04
15099590738631Access SARS-CoV-2 IgM QCBeckman Coulter, Inc.QKO2022-05-04
15099590738648Access SARS-CoV-2 IgGBeckman Coulter, Inc.QKO2022-05-04
15099590738655Access SARS-CoV-2 IgG CalibratorBeckman Coulter, Inc.QKO2022-05-04
15099590738662Access SARS-CoV-2 IgG QCBeckman Coulter, Inc.QKO2022-05-04
15099590742744Access SARS-CoV-2 IgG IIBeckman Coulter, Inc.QKO2022-05-04
15099590742751Access SARS-CoV-2 IgG II CalibratorBeckman Coulter, Inc.QKO2022-05-04
15099590742768Access SARS-CoV-2 IgG II QCBeckman Coulter, Inc.QKO2022-05-04
10758750034413VITROSORTHO CLINICAL DIAGNOSTICSQKO2021-11-08
10758750034420VITROSORTHO CLINICAL DIAGNOSTICSQKO2021-11-08
10758750034567VITROSORTHO-CLINICAL DIAGNOSTICS, INC.QKO2021-11-08