FDA.reportPublic FDA data

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
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

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
K223497000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223497000Spectrum Saliva Collection DeviceSpectrum Solutions, LLC2023-02-17QBD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850015033008PackageGS1360In Commercial Distribution
00850015033001PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085001503300810850015033008
00850015033001008500150330018500150330010850015033001

GMDN Terms#

Term, Definition table
TermDefinition
Oral/respiratory tract specimen container IVD, additive/mediumA 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
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
801-569-0465jenny@spectrumsolution.com

Regulatory Flags#

DUNS number
614635782
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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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
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07898996204655Molecular Transport Media (MTM) 3mlA. L. B. LUZQBD2024-08-29
05411967003464InActiv BlueFertipro NVQBD2024-08-14
05411967003471InActiv BlueFertipro NVQBD2024-08-14
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16973471968784DTPMShenzhen Dakewe Bio-engineering Co., LtdQBD2024-06-07
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B90305154PrimeStore MTMLonghorn Vaccines And Diagnostics, LLCQBD2024-03-20
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B90305151PrimeStore MTMLonghorn Vaccines And Diagnostics, LLCQBD2024-02-07
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06973471968503BioSci™Shenzhen Dakewe Bio-engineering Co., LtdQBD2024-02-01
06973471968510BioSci™Shenzhen Dakewe Bio-engineering Co., LtdQBD2024-02-01
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