FDA.reportPublic FDA data

PrimeStore MTM

Primary DI
B90312033
Brand
PrimeStore MTM
Company
Longhorn Vaccines And Diagnostics, LLC
Model
PSMTM-1203-1000
Device description
PrimeStore MTM 12ml tube 3ml fill carton of 1000
Published
2024-02-09
Public version status
Update
Distribution status
Not 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
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
DEN170029000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN170029000PrimeStore MTMLonghorn Vaccines and Diagnostics, LLC2018-03-19QBD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B90312033PrimaryHIBCC0
B90312031000Unit of UseHIBCC0

Regulatory Flags#

DUNS number
019654346
Device count
1000
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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 From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B90305153PrimeStore MTMPSMTM-0515-10002024-02-27
B90312023PrimeStore MTMPSMTM-1202-10002024-02-09
B90305151PrimeStore MTMPSMTM-0515-502024-02-07
B90312022PrimeStore MTMPSMTM-1202-1002024-02-07
B90312032PrimeStore MTMPSMTM-1203-1002024-02-07
B90305154PrimeStore MTMPSMTM-0515-5002024-03-20
B9030201PrimeStore MTMPSMTM-0201-502025-11-03
B9030315PrimeStore MTM PSMTM-03152025-11-03
B9030515500PrimeStore MTMPSMTM-0515-5002024-03-20
B90305151000PrimeStore MTMPSMTM-0515-10002024-02-27
B903051550PrimeStore MTMPSMTM-0515-502024-02-07
B90312002100PrimeStore MTMPSMTM-1202-1002024-02-07
B9031203100PrimeStore MTMPSMTM-1203-1002024-02-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00609576901911PurSafe+Puritan Medical ProductsQBD2026-07-08
00609576901928PurSafe+Puritan Medical ProductsQBD2026-07-08
00609576901935PurSafe+Puritan Medical ProductsQBD2026-07-08
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
06973843228914Sample Preservative FluidHangzhou Bioer Technology Co., Ltd.QBD2024-07-15
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
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