FDA.reportPublic FDA data

Sample Preservative Fluid

Primary DI
06973843228914
Brand
Sample Preservative Fluid
Company
Hangzhou Bioer Technology Co., Ltd.
Model
BSC82X1-A1
Device description
The Sample Preservative Fluid is intended for the stabilization, transportation, and inactivation of infectious, unprocessed, upper respiratory specimens suspected of containing Influenza A virus. Specimens transported in the Sample Preservative Fluid are stable refrigerated (2-8°C) and at room temperature (20-25°C). The Sample Preservative Fluid is suitable for use with compatible legally marketed molecular diagnostic devices.
Published
2024-07-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
QBDMicrobial Nucleic Acid Storage And Stabilization Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QBDMicrobial Nucleic Acid Storage And Stabilization DeviceMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222771000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222771000Sample Preservative FluidHangzhou Bioer Technology Co., Ltd.2024-06-26QBD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06973843228914PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06973843228914069738432289146973843228914

GMDN Terms#

Term, Definition table
TermDefinition
General specimen collection kit IVD, clinicalA collection of in vitro diagnostic devices intended exclusively for professional use for the collection, and preservation and/or transport, of more than one type of clinical specimen (e.g., urine, faeces, sputum, mucous, vaginal secretions) derived from different body regions for in vitro diagnostic investigation [e.g., nucleic acid technique (NAT), histopathology]. The kit consists of a specimen sampling/collection tool(s) [e.g., swab, brush, spatula], and a covered specimen receptacle with or without an additive/medium (e.g., preservation solution, microbiological medium). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
545256935
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06973843220277BIOER GeneExplorer Thermal CyclerGE-96G2023-01-11
06973843220376BIOER GeneExplorer Thermal CyclerGE-48DS2023-01-11
06973843220383BIOER GeneExplorer Thermal CyclerGE-384G2023-01-11
06973843220390BIOER GeneExplorer Thermal CyclerGE-4I2023-01-11
06973843220420BIOER GeneExplorer Thermal CyclerGE-48D2023-01-11
06973843220482BIOER GeneExplorer Thermal CyclerGE-96S2023-01-11
06973843220499BIOER GeneExplorer Thermal CyclerGE-48DG2023-01-11
06973843220505BIOER LineGene MiniS Fluorescent Quantitative Detection SystemFQD-16B(EA2)2023-01-11
06973843220512BIOER LineGene MiniS Fluorescent Quantitative Detection SystemFQD-16B(EA4)2023-01-11
06973843220529BIOER LineGene 9600 Plus Fluorescent Quantitative Detection SystemFQD-96A(EA2)2023-01-11
06973843220536BIOER LineGene 9600 Plus Fluorescent Quantitative Detection SystemFQD-96A(EA4)2023-01-11
06973843220543BIOER LineGene 9600 Plus Fluorescent Quantitative Detection SystemFQD-96A(EA5)2023-01-11
06973843220550BIOER LineGene 9600 Plus Fluorescent Quantitative Detection SystemFQD-96A(EA6)2023-01-11
06973843220567BIOER QuantGene 9600 Fluorescent Quantitative Detection SystemFQD-96C(EA4)2023-01-11
06973843220574BIOER QuantGene 9600 Fluorescent Quantitative Detection SystemFQD-96C(EA5)2023-01-11
06973843220581BIOER QuantGene 9600 Fluorescent Quantitative Detection SystemFQD-96C(EA6)2023-01-11
06973843220802careSTART™ Q1 AmplifierTQA-E001822025-02-11
06973843220864GenePure Pro 16H Nucleic Acid Purification SystemNPA-16H2025-02-11
06973843220871Thermo Cell Mixing Block MB-1012025-02-11
06973843220888Thermo Shaker Mixing Block MB-2022025-02-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974679160201ZHEJIANG GENE SCIENCEZHEJIANG GENE SCIENCE CO., LTD.QBD2026-05-11
06974679160768ZHEJIANG GENE SCIENCEZHEJIANG GENE SCIENCE CO., LTD.QBD2026-05-11
10850045030008Magbio Genomics, Inc.Magbio Genomics, Inc.QBD2026-03-27
00850049735490Magbio Genomics, Inc.Magbio Genomics, Inc.QBD2026-03-27
00850045030018Magbio Genomics, Inc.Magbio Genomics, Inc.QBD2026-03-27
B9030201PrimeStore MTMLonghorn Vaccines And Diagnostics, LLCQBD2025-11-03
B9030315PrimeStore MTM Longhorn Vaccines And Diagnostics, LLCQBD2025-11-03
07898996204648Molecular Transport Media (MTM) 2mlA. L. B. LUZQBD2024-08-29
07898996204655Molecular Transport Media (MTM) 3mlA. L. B. LUZQBD2024-08-29
05411967003464InActiv BlueFertipro NVQBD2024-08-14
05411967003471InActiv BlueFertipro NVQBD2024-08-14
16973471968784DTPMShenzhen Dakewe Bio-engineering Co., LtdQBD2024-06-07
26973471968781DTPMShenzhen Dakewe Bio-engineering Co., LtdQBD2024-06-07
06973471968763DTPMShenzhen Dakewe Bio-engineering Co., LtdQBD2024-05-20
B90305154PrimeStore MTMLonghorn Vaccines And Diagnostics, LLCQBD2024-03-20
B9030515500PrimeStore MTMLonghorn Vaccines And Diagnostics, LLCQBD2024-03-20
B90305153PrimeStore MTMLonghorn Vaccines And Diagnostics, LLCQBD2024-02-27
B90305151000PrimeStore MTMLonghorn Vaccines And Diagnostics, LLCQBD2024-02-27
B90312023PrimeStore MTMLonghorn Vaccines And Diagnostics, LLCQBD2024-02-09
B90312033PrimeStore MTMLonghorn Vaccines And Diagnostics, LLCQBD2024-02-09
B90305151PrimeStore MTMLonghorn Vaccines And Diagnostics, LLCQBD2024-02-07
B90312022PrimeStore MTMLonghorn Vaccines And Diagnostics, LLCQBD2024-02-07
B90312032PrimeStore MTMLonghorn Vaccines And Diagnostics, LLCQBD2024-02-07
B903051550PrimeStore MTMLonghorn Vaccines And Diagnostics, LLCQBD2024-02-07
B90312002100PrimeStore MTMLonghorn Vaccines And Diagnostics, LLCQBD2024-02-07
B9031203100PrimeStore MTMLonghorn Vaccines And Diagnostics, LLCQBD2024-02-07
06973471968503BioSci™Shenzhen Dakewe Bio-engineering Co., LtdQBD2024-02-01
06973471968510BioSci™Shenzhen Dakewe Bio-engineering Co., LtdQBD2024-02-01
06973471968527BioSci™Shenzhen Dakewe Bio-engineering Co., LtdQBD2024-02-01
00860011194507DNA/RNA Shield™ SafeCollect Saliva Collection KitBlue Life Solutions, LLCQBD2024-01-01