FDA.reportPublic FDA data

MesaLabs

Primary DI
M9850200310
Brand
MesaLabs
Company
MESA LABORATORIES, INC.
Model
02.0031
Catalog number
02.0031
Device description
Standard Buffer Solution pH 7.00 1 qt.
Published
2015-07-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
JCCPh Buffer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JCCPh BufferPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M9850202101PackageHIBCC6In Commercial Distribution
M9850200310PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
pH-adjusted buffer solution IVDA pH-adjusted buffer solution intended to be used alone or in combination with other IVDs in the processing, staining, and/or testing of clinical laboratory specimens.

Regulatory Flags#

DUNS number
102530326
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M98551000T1Dual Spore Strips - Test10e5/10e65-1000T2017-10-20
M985CIDHI1Mesa Labs Dry Heat Indicator LabelsCI-DHICI-DHI2016-11-30
M985CISSIX1ProChem SSE EmulatorCI-SSIXCI-SSIX2016-11-30
M985CIBDTLF0Bowie Dick Type TestProChemCI-BDTLF2016-10-24
M9850141001Spore Strip10e41-41002025-01-15
M9850161001Spore Strip - EO/Dry Heat10e61-61002025-01-15
M9850341001Spore Strip10e43-41002025-01-15
M9850351001Spore Strip Steam & Chemiclave10e53-51002025-01-15
M9850361001Spore Strip Steam & Chemiclave10e63-61002025-01-15
M985051000C1Dual Spore Strips - Control10e5, 10e65-1000C2025-01-15
M985051000T1Dual Spore Strips - Test10e5, 10e65-1000T2025-01-15
M985055100T1Dual Spore Strip - Test10e5, 10e65-5100T2025-01-15
M9850141000Spore Strip10e41-41002025-01-15
M9850161000Spore Strip - EO/Dry Heat10e61-61002025-01-15
M9850341000Spore Strip10e43-41002025-01-15
M9850351000Spore Strip Steam & Chemiclave10e53-51002025-01-15
M9850361000Spore Strip Steam & Chemiclave10e63-61002025-01-15
M985051000C0Dual Spore Strips - Control10e5, 10e65-1000C2025-01-15
M985051000T0Dual Spore Strips - Test10e5, 10e65-1000T2025-01-15
M985HFY5201017950 HealthFirst Mail-In Spore Testing Service, 52 TestsHF-Y52HF-Y522024-12-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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04015630971008Antibody DiluentVentana Medical Systems, Inc.JCC2025-12-15
04015630972432ULTRA Cell Conditioning Solution (ULTRA CC1)Ventana Medical Systems, Inc.JCC2025-12-15
04015630985012ISH Probe DiluentVentana Medical Systems, Inc.JCC2025-12-15
00810170553585IHCSlmp, LLCJCC2025-03-31
00810170553592IHCSlmp, LLCJCC2025-03-31
08435256719499TBS Tween 20 Buffer 10X q.s. 10LVITRO SAJCC2025-02-20
08435804515078TBS Tween 20 Buffer 10XVITRO SAJCC2025-02-20
00348783012699BufferProPREMIER DENTAL PRODUCTS COMPANYJCC2024-12-18
00860011780540Chemical Service Labs, LLCProtean Resources, LLC.JCC2024-03-18
00860011780557Chemical Service Labs, LLCProtean Resources, LLC.JCC2024-03-18
00860011780564Chemical Service Labs, LLCProtean Resources, LLC.JCC2024-03-18
00860011780595Chemical Service Labs, LLCProtean Resources, LLC.JCC2024-03-18
07540207107803EasySep™ BufferStemcell Technologies Canada IncJCC2024-02-08
00380740136994AlinityAbbott Ireland DiagnosticsJCC2023-11-16
00860001977349OnsetOnpharma CompanyJCC2023-06-01
00810047421047N/AScientific Device Laboratory, Inc.JCC2023-01-31
00810047421054N/AScientific Device Laboratory, Inc.JCC2023-01-31
00847627014528PBS Plus 10XBIOCARE MEDICAL LLCJCC2022-12-07
00847627014559Immunocare PBS 10XBIOCARE MEDICAL LLCJCC2022-12-07
00847627014610TBSplus 10XBIOCARE MEDICAL LLCJCC2022-12-07
00847627014627Automation Tween 20, 20XBIOCARE MEDICAL LLCJCC2022-12-07
00847627014634Immunocare TBS Wash Buffer 10XBIOCARE MEDICAL LLCJCC2022-12-07
0084762701466520% Tween 20BIOCARE MEDICAL LLCJCC2022-12-07
0084762701467220% Tween 20BIOCARE MEDICAL LLCJCC2022-12-07
0084762701468920% Tween 20BIOCARE MEDICAL LLCJCC2022-12-07
00847627014641TBS Auto Wash Buffer 20XBIOCARE MEDICAL LLCJCC2022-09-23
00847627014658TBS Auto Wash Buffer 40XBIOCARE MEDICAL LLCJCC2022-09-23
00816085023311Alpha-Tec SystemsAlpha-TEC Systems, Inc.JCC2022-08-10
00816085023328Alpha-Tec SystemsAlpha-TEC Systems, Inc.JCC2022-08-10
00816085020259Alpha-Tec SystemsAlpha-TEC Systems, Inc.JCC2022-08-10