FDA.reportPublic FDA data

NeuMoDx™ Lysis Buffer 5

Primary DI
00814278020864
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
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078667309
Device count
4
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
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
10814278020014NeuMoDx™ 288 Molecular System5001005001002019-03-29
10814278020724NeuMoDx™ 96 Molecular System5002005002002019-03-29
10814278020861NeuMoDx™ Lysis Buffer 54009004009002021-12-13
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

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Primary DI, Brand, Company table
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