FDA.reportPublic FDA data

NeuMoDx™ Lysis Buffer 6

Primary DI
10814278021219
Brand
NeuMoDx™ Lysis Buffer 6
Company
Neumodx Molecular, Inc.
Model
401700
Catalog number
401700
Device description
NeuMoDx™ Lysis Buffer 6
Published
2020-03-19
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
PPMGeneral Purpose Reagent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PPMGeneral Purpose ReagentPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10814278021219PrimaryGS10
00814278021212Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081427802121910814278021219
00814278021212008142780212128142780212120814278021212

GMDN Terms#

Term, Definition table
TermDefinition
Nucleic acid sequencing reagent kit IVDA collection of reagents and other associated materials intended to be used on-board a nucleic acid sequencing instrument for the genetic analysis of a clinical specimen. It typically consists of buffers, primers, enzymes (e.g., DNA polymerase, DNA ligase) and deoxynucleotides (dNTPs). It does not contain analyte-specific reagents and is not intended to be used for whole genome or complementary deoxyribonucleic acid (cDNA) library construction.

Regulatory Flags#

DUNS number
078667309
Device count
4
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10814278020014NeuMoDx™ 288 Molecular System5001005001002019-03-29
10814278020724NeuMoDx™ 96 Molecular System5002005002002019-03-29
10814278020861NeuMoDx™ Lysis Buffer 54009004009002021-12-13
10814278021257NeuMoDx™ Viral Lysis Buffer4016004016002020-03-20
10814278021264NeuMoDx SARS-CoV-2 Test Strip3008003008002020-04-23
10814278021301NeuMoDx™ Vantage Viral Lysis Buffer4015004015002021-12-13
10814278020045NeuMoDxTM GBS Test Strip2004002004002019-04-03
10814278020199NeuMoDxTM LDT Master Mix, DNA2101002101002019-03-29
10814278020205NeuMoDxTM LDT Master Mix, RNA3101003101002019-03-29
10814278020212NeuMoDxTM Wash Reagent4001004001002019-03-29
10814278020229NeuMoDxTM Release Reagent4002004002002019-03-29
10814278020236NeuMoDxTM Lysis Buffer 14004004004002019-03-29
10814278020243NeuMoDxTM Lysis Buffer 24005004005002019-03-29
10814278020250NeuMoDxTM Lysis Buffer 34006004006002019-03-29
10814278020267NeuMoDxTM Lysis Buffer 44007004007002019-03-29
10814278020274NeuMoDxTM Cartridge1001001001002019-03-29
10814278020281NeuMoDxTM Extraction Plate1002001002002019-03-29
10814278020304NeuMoDxTM LDT Probe/Primer Strip1004001004002019-03-29
10814278020663NeuMoDxTM Biohazard Waste Bag6001006001002019-03-29
00814278020864NeuMoDx™ Lysis Buffer 54009004009002021-12-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00846405014194Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-09
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00846405012428Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012435Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
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00846405012473Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
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00846405017140Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405023219Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405023271Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08