FDA.reportPublic FDA data

Co-Dx PCR Sample Prep

Primary DI
00850091808005
Brand
Co-Dx PCR Sample Prep
Company
Co-Diagnostics, Inc.
Model
2
Catalog number
LYSS-ASY-0001
Published
2026-10-16
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

Product Codes#

Code, Name table
CodeName
JRGBlock, Heating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JRGBlock, HeatingClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850091808005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850091808005008500918080058500918080050850091808005

GMDN Terms#

Term, Definition table
TermDefinition
Heating block IVDAn electrically-powered device which is primarily a heating element, with or without a thermostat, that is built into a compact block and intended to be used as a stable dry heat source to heat in vitro diagnostic specimens/laboratory materials. It is typically a stand-alone instrument, or an interchangeable component of an in vitro diagnostic instrument/analyser. It is available in various sizes to accommodate microplates of varying sizes, and may include covers to minimize evaporation from microplates.

Regulatory Flags#

DUNS number
080578422
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 Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06936895315780BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JRG2026-07-30
06973843220871Thermo Cell Mixing Block Hangzhou Bioer Technology Co., Ltd.JRG2025-02-11
06973843220888Thermo Shaker Mixing Block Hangzhou Bioer Technology Co., Ltd.JRG2025-02-11
06973843220895ThermoQHangzhou Bioer Technology Co., Ltd.JRG2025-02-11
06973843220901ThermoQHangzhou Bioer Technology Co., Ltd.JRG2025-02-11
06973843220918ThermoQHangzhou Bioer Technology Co., Ltd.JRG2025-02-11
06973843220925ThermoQHangzhou Bioer Technology Co., Ltd.JRG2025-02-11
06973843220932ThermoQHangzhou Bioer Technology Co., Ltd.JRG2025-02-11
06973843220949ThermoQHangzhou Bioer Technology Co., Ltd.JRG2025-02-11
06973843220956ThermoQHangzhou Bioer Technology Co., Ltd.JRG2025-02-11
06973843220963ThermoQHangzhou Bioer Technology Co., Ltd.JRG2025-02-11
06973843220970ThermoQHangzhou Bioer Technology Co., Ltd.JRG2025-02-11
06973843220987ThermoQHangzhou Bioer Technology Co., Ltd.JRG2025-02-11
06973843220994ThermoQHangzhou Bioer Technology Co., Ltd.JRG2025-02-11
06973843221007ThermoQHangzhou Bioer Technology Co., Ltd.JRG2025-02-11
06973843221014ThermoQHangzhou Bioer Technology Co., Ltd.JRG2025-02-11
06973843221021ThermoQHangzhou Bioer Technology Co., Ltd.JRG2025-02-11
06973843221038ThermoQHangzhou Bioer Technology Co., Ltd.JRG2025-02-11
06973843221052ThermoQHangzhou Bioer Technology Co., Ltd.JRG2025-02-11
06973843221069ThermoQHangzhou Bioer Technology Co., Ltd.JRG2025-02-11
06973843221076ThermoQHangzhou Bioer Technology Co., Ltd.JRG2025-02-11
06973843221083ThermoQHangzhou Bioer Technology Co., Ltd.JRG2025-02-11
06973843221120Thermo CellHangzhou Bioer Technology Co., Ltd.JRG2025-02-11
06973843221137Thermo CellHangzhou Bioer Technology Co., Ltd.JRG2025-02-11
06973843221144ThermoQHangzhou Bioer Technology Co., Ltd.JRG2025-02-11
06936895301318BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JRG2023-07-06
06936895301325BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JRG2023-07-06
06936895301332BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JRG2023-07-06
06936895301349BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JRG2023-07-06
09349458005443ThermoBrite Elite InstrumentLEICA BIOSYSTEMS MELBOURNE PTY LTDJRG2022-07-18