FDA.reportPublic FDA data

NeuMoDx™ Viral Lysis Buffer

Primary DI
10814278021257
Brand
NeuMoDx™ Viral Lysis Buffer
Company
Neumodx Molecular, Inc.
Model
401600
Catalog number
401600
Device description
NeuMoDx™ Viral Lysis Buffer
Published
2020-03-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
10814278021257PrimaryGS10
00814278021250Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081427802125710814278021257
00814278021250008142780212508142780212500814278021250

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume1Liter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature15 Degrees Celsius28 Degrees Celsius

Regulatory Flags#

DUNS number
078667309
Device count
2
DM exempt
true
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
10814278021219NeuMoDx™ Lysis Buffer 64017004017002020-03-19
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

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Primary DI, Brand, Company table
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05407010129861T-32 1000L bagLonza VerviersPPM2026-03-26
05407010129878T-32 200L bagLonza VerviersPPM2026-03-26
05407010129885NaAc-35 - 1000L bagLonza VerviersPPM2026-03-26
05407010129892NaAc-35 - 200L BagLonza VerviersPPM2026-03-26
05407010129908NaAc-35 -1L Sample bagLonza VerviersPPM2026-03-26
05407010129915NaP-55 - 1000LLonza VerviersPPM2026-03-26
05407010129922NaP-55 - 1L sample bagLonza VerviersPPM2026-03-26
05407010129939NaAc-36 -1000L BagLonza VerviersPPM2026-03-26
05407010129946NaAc-36 -1L Sample BagLonza VerviersPPM2026-03-26
05407010129953NaAc-36 -500L BagLonza VerviersPPM2026-03-26
05407010129960NaAc-34 -1000L BagLonza VerviersPPM2026-03-26
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05407010129243KH-020 BF-1 1L Sample BagLonza VerviersPPM2025-10-30
05407010129250KH-020 BF-1 1000L BagLonza VerviersPPM2025-10-30
05407010129267KH-020 BF-1 500L BagLonza VerviersPPM2025-10-30
05407010129274NTT-001-L Buffer - 1L bag SAMPLELonza VerviersPPM2025-10-30
05407010129281NTT-001-L Buffer - 200L bagLonza VerviersPPM2025-10-30
05407010129298NTT-001-L Buffer - 500L bagLonza VerviersPPM2025-10-30
05407010129304NTT-001-K : 1M NaCl - 1L bag SAMPLELonza VerviersPPM2025-10-30
05407010129311NTT-001-K : 1M NaCl - 200L bagLonza VerviersPPM2025-10-30
05407010129328NTT-001-K : 1M NaCl - 500L bagLonza VerviersPPM2025-10-30
05407010129335NTT-001-R : 150 mM NaCl - 1000L bagLonza VerviersPPM2025-10-30