FDA.reportPublic FDA data

Geenius

Primary DI
03610522162239
Brand
Geenius
Company
Bio-RAD Laboratories, Inc.
Model
12012482
Catalog number
12012482
Device description
Geenius Blood Donor IFU & APF v2.0 binder
Published
2023-07-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
QHMSerology tests used for infectious disease screening of blood and plasma donations

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QHMSerology Tests Used For Infectious Disease Screening Of Blood And Plasma DonationsMicrobiologyU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03610522162239PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03610522162239036105221622393610522162239

GMDN Terms#

Term, Definition table
TermDefinition
HIV1/HIV2 antibody IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to human immunodeficiency virus 1 and 2 (HIV1/HIV2) in a clinical specimen, using a chemiluminescent immunoassay method.

Device Sizes#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)224-6723TechSupport.USSD@bio.rad.com

Regulatory Flags#

DUNS number
844766394
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00847661000778Lyphochek7447442016-09-12
00847661000785Lyphochek7457452016-09-12
00847661000792Lyphochek7467462016-09-12
00847661001027Lyphochek5975972016-09-12
00847661001034Lyphochek5985982016-09-12
00847661001041Lyphochek5995992016-09-12
00847661001898Lyphochek598X598X2016-09-12
00847661001959Lyphochek745X745X2016-09-12
0361052031061896AN96AN-BPU-QUEST96AN-BPU-QUEST2016-09-12
03610520547663ANA PLATE196AN-BPU196AN-BPU2016-09-12
0361052056045796AN96AN-BPU-TRINITY96AN-BPU-TRINITY2016-09-12
03610520569184ANA PLATE196AN-BPU-ED196AN-BPU-ED2016-09-12
00847661000082Liquichek1071072016-09-12
00847661000099Liquichek1081082016-09-12
00847661000105Liquichek1111112016-09-12
00847661000112Liquichek1121122016-09-12
00847661000129Liquichek1181182016-09-12
00847661000204Liquichek1291292016-09-12
00847661000211Liquichek1311312016-09-19
00847661000228Liquichek1301302016-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336183106Elecsys Anti-HBc IIRoche Diagnostics GmbHQHM2025-02-19
07613336183120Elecsys HIV DuoRoche Diagnostics GmbHQHM2025-02-19
07613336183045PreciControl Release HIV Gen IIRoche Diagnostics GmbHQHM2025-02-19
07613336228487Elecsys Anti-HBc IIRoche Diagnostics GmbHQHM2025-02-19
07613336228500Elecsys HIV DuoRoche Diagnostics GmbHQHM2025-02-19
07613336183212PreciControl HIV Gen IIRoche Diagnostics GmbHQHM2025-02-19
07613336183229PreciControl HIV; HIV-2+GrpORoche Diagnostics GmbHQHM2025-02-19
07613336183052Elecsys Anti-HCV IIRoche Diagnostics GmbHQHM2025-02-18
07613336183090Elecsys HTLV-I/IIRoche Diagnostics GmbHQHM2025-02-18
07613336183113Elecsys ChagasRoche Diagnostics GmbHQHM2025-02-18
07613336182970PreciControl Release Anti-HCVRoche Diagnostics GmbHQHM2025-02-18
07613336183014PreciControl Release HTLVRoche Diagnostics GmbHQHM2025-02-18
07613336183021PreciControl Release Anti-HBc IIRoche Diagnostics GmbHQHM2025-02-18
07613336183038PreciControl Release ChagasRoche Diagnostics GmbHQHM2025-02-18
07613336228432Elecsys Anti-HCV IIRoche Diagnostics GmbHQHM2025-02-18
07613336228470Elecsys HTLV-I/IIRoche Diagnostics GmbHQHM2025-02-18
07613336228494Elecsys ChagasRoche Diagnostics GmbHQHM2025-02-18
07613336183144PreciControl Anti-HCVRoche Diagnostics GmbHQHM2025-02-18
07613336183182PreciControl HTLVRoche Diagnostics GmbHQHM2025-02-18
07613336183199PreciControl Anti-HBc IIRoche Diagnostics GmbHQHM2025-02-18
07613336183205PreciControl ChagasRoche Diagnostics GmbHQHM2025-02-18
07613336183076Elecsys HBsAg IIRoche Diagnostics GmbHQHM2024-11-07
07613336182994PreciControl Release HBsAg IIRoche Diagnostics GmbHQHM2024-11-07
07613336228456Elecsys HBsAg IIRoche Diagnostics GmbHQHM2024-11-07
07613336183137Elecsys HBsAg II Auto ConfirmRoche Diagnostics GmbHQHM2024-11-07
07613336183168PreciControl HBsAg IIRoche Diagnostics GmbHQHM2024-11-07
03610521168942GeeniusBio-RAD Laboratories, Inc.QHM2023-07-28
03610522162260GeeniusBio-RAD Laboratories, Inc.QHM2023-07-28
03610522168064GeeniusBio-RAD Laboratories, Inc.QHM2023-07-28