FDA.reportPublic FDA data

COVID-19 Coronavirus Real Time PCR Kit

Primary DI
06973342000158
Brand
COVID-19 Coronavirus Real Time PCR Kit
Company
Jiangsu Bioperfectus Technologies Co., Ltd.
Model
50 Tests
Published
2023-01-30
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
QQXRespiratory Specimen Nucleic Acid Sars-Cov-2 Test

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QQXRespiratory Specimen Nucleic Acid Sars-Cov-2 TestMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06973342000158PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06973342000158069733420001586973342000158

GMDN Terms#

Term, Definition table
TermDefinition
SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2) in a clinical specimen, using a nucleic acid technique (NAT). This test is used to aid the diagnosis of coronavirus disease (COVID-19) infection.

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
06973342000219Nucleic Acid Extraction SystemSSNP-9600A2023-02-02
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

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