FDA.reportPublic FDA data

QXDx

Primary DI
03610522040131
Brand
QXDx
Company
BIO-RAD LABORATORIES, INC.
Model
12008019
Catalog number
12008019
Device description
QXDx Automated Droplet Generator
Published
2026-08-14
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
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
PHGDroplet digital PCR system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PHGDroplet Digital Pcr SystemClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03610522040131PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03610522040131036105220401313610522040131

GMDN Terms#

Term, Definition table
TermDefinition
Nucleic acid amplification mastermix kit IVDA collection of reagents and other associated materials [enzymes, buffers, nucleotides, magnesium chloride (MgCl2)], intended to be used in combination with sequence-specific primers, probes and/or controls (not included) to facilitate the amplification of a target nucleic acid sequence [i.e., deoxyribonucleic acid (DNA) or ribonucleic acid (RNA)] in a clinical specimen, using a nucleic acid amplification technique [e.g., polymerase chain reaction (PCR), loop-mediated isothermal amplification (LAMP)].

Device Sizes#

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

Contacts#

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

Regulatory Flags#

DUNS number
132528295
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
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
03610522040148QXDx12008020120080202026-08-19
03610522991303QX60012024779120247792026-08-14
03610523006433QXDx12024810120248102026-08-14
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03610522040148QXDxBIO-RAD LABORATORIES, INC.PHG2026-08-19
03610522991303QX600BIO-RAD LABORATORIES, INC.PHG2026-08-14
03610523006433QXDxBIO-RAD LABORATORIES, INC.PHG2026-08-14
04053228048770QIAcuityDx® FourQIAGEN GmbHPHG2024-09-30
04053228049685QIAcuityDx® Nanoplate 26k 24-wellQIAGEN GmbHPHG2024-09-30
06974689624212TARGETINGONETargetingOne Technology (Beijing) CorporationPHG2023-10-20
06974689624229TARGETINGONETargetingOne Technology (Beijing) CorporationPHG2023-10-20
06974689625080TARGETINGONETargetingOne Technology (Beijing) CorporationPHG2023-10-20
06974689625097TARGETINGONETargetingOne Technology (Beijing) CorporationPHG2023-10-20
06974689625103TARGETINGONETargetingOne Technology (Beijing) CorporationPHG2023-10-20
06974689625172TARGETINGONETargetingOne Technology (Beijing) CorporationPHG2023-10-20
06974689625189TARGETINGONETargetingOne Technology (Beijing) CorporationPHG2023-10-20