FDA.reportPublic FDA data

Nucleic Acid Extraction System

Primary DI
06973342000219
Brand
Nucleic Acid Extraction System
Company
Jiangsu Bioperfectus Technologies Co., Ltd.
Model
SSNP-9600A
Published
2023-02-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JJHClinical Sample Concentrator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJHClinical Sample ConcentratorClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06973342000219PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06973342000219069733420002196973342000219

GMDN Terms#

Term, Definition table
TermDefinition
Nucleic acid sample preparation instrument IVDAn electrically-powered automated or semi-automated laboratory instrument intended to be used for the automated pre-analytical preparation of samples for downstream nucleic acid analysis. The instrument may be used to prepare various sample types through one or more pre-analytical steps which may include cell disruption, lysis, nucleic acid extraction, enzymatic digestion and/or nucleic acid purification.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
548535842
Device count
1
DM exempt
true
Premarket exempt
true
Kit
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
06973342002466Nucleic Acid Extraction Rapid Kit (Magnetic Bead Method)SDKF60101-32T(16*2)2023-02-02
06973342000110Nucleic Acid Extraction SystemSSNP-3000A2023-02-02
06973342000189Nucleic Acid Extraction SystemSSNP-2000B2023-02-02
06973342000240Nucleic Acid Extraction Rapid Kit (Magnetic Bead Method)SDKF60101-32T(8*4)2023-02-02
06973342000257Real-time PCR SystemSTC-96A PLUS2023-02-02
06973342000530COVID-19 Coronavirus Real Time PCR Kit25 Tests2023-02-02
06973342000547Nucleic Acid Extraction Rapid Kit (Magnetic Bead Method)SDKF60101-48T(8*6)2023-02-02
06973342000554Nucleic Acid Extraction Rapid Kit (Magnetic Bead Method)SDKF60101-96T2023-02-02
06973342001780Whole Blood DNA Extraction Kit (Magnetic Bead Method)48 Tests (8*6)2023-02-02
06973342001797Whole Blood DNA Extraction Kit (Magnetic Bead Method)96 Tests2023-02-02
06973342001803Nucleic Acid Extraction SystemSMPE-9602023-02-02
06973342002442Nucleic Acid Extraction Rapid Kit (Magnetic Bead Method)SDKF60101D-32T2023-02-02
06973342002459Nucleic Acid Extraction Rapid Kit (Magnetic Bead Method)SDKF60101-48T(16*3)2023-02-02
06973342002473Real-time PCR SystemSTC-96A 2023-02-02
06973342002480Viral Nucleic Acid Isolation Kit (Silica-Based Spin Column)50 Tests2023-02-02
06973342002497Viral Nucleic Acid Extraction Kit (Magnetic Bead Method)32 Tests (8*4)2023-02-02
06973342002503Viral Nucleic Acid Extraction Kit (Magnetic Bead Method)48 Tests (8*6)2023-02-02
06973342002510Viral Nucleic Acid Extraction Kit (Magnetic Bead Method)96 Tests2023-02-02
06973342002527Bacteria DNA Extraction Kit (Magnetic Bead Method)48 Tests2023-02-02
06973342002534Bacteria DNA Extraction Kit (Magnetic Bead Method)96 Tests2023-02-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B708ABFVR020XCELLAPEX BIOLOGIX , LLCJJH2026-03-26
06955792702844Nucleic Acid Extraction and Purification Kit 1.0Sansure Biotech Inc.JJH2026-03-25
06955792702851Nucleic Acid Extraction and Purification Kit 1.0Sansure Biotech Inc.JJH2026-03-25
06955792702868Nucleic Acid Extraction and Purification Kit 2.0Sansure Biotech Inc.JJH2026-03-25
06955792702875Nucleic Acid Extraction and Purification Kit 2.0Sansure Biotech Inc.JJH2026-03-25
06955792702882Nucleic Acid Extraction and Purification Kit 3.0Sansure Biotech Inc.JJH2026-03-25
06955792702899Nucleic Acid Extraction and Purification Kit 3.0Sansure Biotech Inc.JJH2026-03-25
04053228040576EZ2 Connect MDxQIAGEN GmbHJJH2026-03-03
00849811081835Maxwell® CSC Rapid ccfDNA KitPROMEGA CORPORATIONJJH2026-02-16
00849811083778Maxwell® CSC XtractAll FFPE DNA/RNA KitPROMEGA CORPORATIONJJH2026-02-16
04719882810046IntelliPrep TRIO 240 Sample Preparation SystemPlexBio Co., Ltd.JJH2026-01-28
04719882810237IntelliPrep Blood Genomic DNA Extraction Kit PlexBio Co., Ltd.JJH2026-01-28
04719882810268IntelliPrep FFPE DNA Extraction Kit PlexBio Co., Ltd.JJH2026-01-28
04719882810282IntelliPrep FFPE RNA Extraction KitPlexBio Co., Ltd.JJH2026-01-28
04719882810299IntelliPrep cfDNA Extraction KitPlexBio Co., Ltd.JJH2026-01-28
04719880121397TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880121403TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880121441TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880121458TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880122097TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880122103TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880122158TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880122165TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880122370TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880122387TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880122431TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880122660TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880122707TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880122882TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07
04719880122899TANBead Nucleic Acid Extraction KitTaiwan Advanced Nanotech INC.JJH2026-01-07