Home GUDID 00850015033001 BioMAX
Primary DI 00850015033001
Brand BioMAX
Company Spectrum Solutions L.L.C.
Model SDNA 1000
Catalog number 2019162
Device description The Spectrum Solutions BioMAX Specimen Collection device consists of a plastic tube designed for the collection of human saliva samples, a funnel, a cap with a stem flare, and a fluid chamber containing Spectrum’s inactivating media. Sample collection is conducted under the supervision of a Health care provider. The user deposits their saliva into the collection tube with the aid of the attached funnel, the user removes the funnel and replaces it with the cap. Upon twisting and closing the cap, the stabilizing solution is released into the tube and mixed with the saliva.
Published 2023-06-21
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 Code Name QBD Microbial Nucleic Acid Storage And Stabilization Device
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class QBD Microbial Nucleic Acid Storage And Stabilization Device Microbiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10850015033008 Package GS1 360 In Commercial Distribution 00850015033001 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10850015033008 10850015033008 00850015033001 00850015033001 850015033001 0850015033001
GMDN Terms# Term, Definition table Term Definition Oral/respiratory tract specimen container IVD, additive/medium A covered receptacle containing an additive and/or medium [e.g., saline, sodium azide, buffer solution, microbiological medium (e.g., Amies, Stuart, viral transport/inactivation medium)] intended to be used in the home and clinical settings for the collection, and preservation and/or transport, of a saliva/oral, nasal, nasopharyngeal, oropharyngeal, and/or lower respiratory tract specimen (e.g., sputum) [excluding breath specimen], for in vitro diagnostic investigation (e.g., COVID-19 screening). It does not contain patient-contact specimen sampling/extraction devices such as swabs/brushes. This is a single-use device.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 15 Degrees Celsius 30 Degrees Celsius
Regulatory Flags# DUNS number 614635782 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit true Combination product false Lot or batch true Serial number false 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 Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 07898996204648 Molecular Transport Media (MTM) 2ml A. L. B. LUZ QBD 2024-08-29 07898996204655 Molecular Transport Media (MTM) 3ml A. L. B. LUZ QBD 2024-08-29 05411967003471 InActiv Blue Fertipro NV QBD 2024-08-14 06973843228914 Sample Preservative Fluid Hangzhou Bioer Technology Co., Ltd. QBD 2024-07-15 26973471968781 DTPM Shenzhen Dakewe Bio-engineering Co., Ltd QBD 2024-06-07 06973471968763 DTPM Shenzhen Dakewe Bio-engineering Co., Ltd QBD 2024-05-20 B9030515500 PrimeStore MTM Longhorn Vaccines And Diagnostics, LLC QBD 2024-03-20 B90305151000 PrimeStore MTM Longhorn Vaccines And Diagnostics, LLC QBD 2024-02-27 B903051550 PrimeStore MTM Longhorn Vaccines And Diagnostics, LLC QBD 2024-02-07 B90312002100 PrimeStore MTM Longhorn Vaccines And Diagnostics, LLC QBD 2024-02-07 B9031203100 PrimeStore MTM Longhorn Vaccines And Diagnostics, LLC QBD 2024-02-07 06973471968503 BioSci™ Shenzhen Dakewe Bio-engineering Co., Ltd QBD 2024-02-01 06973471968510 BioSci™ Shenzhen Dakewe Bio-engineering Co., Ltd QBD 2024-02-01 06973471968527 BioSci™ Shenzhen Dakewe Bio-engineering Co., Ltd QBD 2024-02-01 00860011194507 DNA/RNA Shield™ SafeCollect Saliva Collection Kit Blue Life Solutions, LLC QBD 2024-01-01 06973471960507 Dakewe Shenzhen Dakewe Bio-engineering Co., Ltd QBD 2023-02-21 06973471960514 Dakewe Shenzhen Dakewe Bio-engineering Co., Ltd QBD 2023-02-21 06973471960521 Dakewe Shenzhen Dakewe Bio-engineering Co., Ltd QBD 2023-02-21 06973471960538 Dakewe Shenzhen Dakewe Bio-engineering Co., Ltd QBD 2023-02-21 06973471960545 Dakewe Shenzhen Dakewe Bio-engineering Co., Ltd QBD 2023-02-21 06973471960552 Dakewe Shenzhen Dakewe Bio-engineering Co., Ltd QBD 2023-02-21 06973471960569 Dakewe Shenzhen Dakewe Bio-engineering Co., Ltd QBD 2023-02-21 06973471960576 Dakewe Shenzhen Dakewe Bio-engineering Co., Ltd QBD 2023-02-21 06973471960583 Dakewe Shenzhen Dakewe Bio-engineering Co., Ltd QBD 2023-02-21 06973471960590 Dakewe Shenzhen Dakewe Bio-engineering Co., Ltd QBD 2023-02-21 06973471960606 Dakewe Shenzhen Dakewe Bio-engineering Co., Ltd QBD 2023-02-21 06973471960613 Dakewe Shenzhen Dakewe Bio-engineering Co., Ltd QBD 2023-02-21 06973843228143 BIOER Sample Preservative Fluid Hangzhou Bioer Technology Co., Ltd. QBD 2023-01-11 00850027600024 DNA/RNA Shield Collection Tube with Swab (1mL) Zymo Research Corp. QBD 2022-03-01 00850027600031 DNA/RNA Shield Collection Tube with Swab (2mL) Zymo Research Corp. QBD 2022-03-01
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