FDA.reportPublic FDA data

NeuMoDx™ Lysis Buffer 5

Primary DI
10814278020861
Brand
NeuMoDx™ Lysis Buffer 5
Company
Neumodx Molecular, Inc.
Model
400900
Catalog number
400900
Device description
NeuMoDx™ Lysis Buffer 5
Published
2021-12-13
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
10814278020861PrimaryGS10
00814278020864Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081427802086110814278020861
00814278020864008142780208648142780208640814278020864

GMDN Terms#

Term, Definition table
TermDefinition
Molecular grade lysis reagent IVDA substance or reactant containing a protein denaturant (e.g., guanidine thiocyanate) intended to be used alone or in combination with other IVDs for the extraction of nucleic acids (e.g., DNA, RNA) from cells in a clinical specimen in preparation for further analysis using a nucleic acid technique (NAT).

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume100Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature18 Degrees Celsius23 Degrees Celsius

Regulatory Flags#

DUNS number
078667309
Device count
4
DM exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
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
10814278021219NeuMoDx™ Lysis Buffer 64017004017002020-03-19
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
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00846405017140Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
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00846405023271Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08