FDA.reportPublic FDA data

MassARRAY Clean Resin 28g

Primary DI
00850010566054
Brand
MassARRAY Clean Resin 28g
Company
AGENA BIOSCIENCE, INC.
Model
8040
Catalog number
8040
Published
2020-09-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
DOPMASS SPECTROMETER, CLINICAL USE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DOPMass Spectrometer, Clinical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850010566054PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850010566054008500105660548500105660540850010566054

GMDN Terms#

Term, Definition table
TermDefinition
Post-PCR cleanup kit IVDA collection of reagents and other associated materials intended to be used for the purification of polymerase chain reaction (PCR) processed clinical specimens prior to downstream nucleic acid analysis. The kit typically consists of various buffer and/or washing solutions and can be used with manual or automated instruments.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(858)882-2725glenn.wise@agenabio.com

Regulatory Flags#

DUNS number
079436896
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850010566023SpectroChip CPM Kit (2x96)10610F10610F2020-09-08
00850010566030SpectroChip CPM Kit (10x96)10600F10600F2020-09-08
00850010566061Calibrant00436004362020-09-08
00850010566009MassARRAAY Dx2600502600502020-09-08
00850010566016CPM Dx31245312452020-09-08
10850010566020SpectroChip CPM Kit (2x96)10610F10610F2020-09-08
10850010566037SpectroChip CPM Kit (10x96)10600F10600F2020-09-08
00850010566047SpectroChip Standalone Chip Only)860886082020-09-08
10850010566068Calibrant00436004362020-09-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336231357cobas i 601 SBLRoche Diagnostics GmbHDOP2025-08-08
07613336231388cobas pro i 601 BLRoche Diagnostics GmbHDOP2025-08-08
07613336231364cobas i 601Roche Diagnostics GmbHDOP2025-07-31
00842365102568Triple Quad™ 4500MDAB SCIEX (MANUFACTURING)DOP2024-06-14
05061024690009SerconSERCON LIMITEDDOP2023-08-30
00816776020254XevoWATERS TECHNOLOGIES CORPORATIONDOP2023-04-06
06438147371815Qsight 210 MD Screening SystemWallac OyDOP2023-03-29
06438147384709Qsight 225 MD Screening SystemWallac OyDOP2023-03-29
00842365100533Citrine Triple Quad™ MS/MSAB SCIEX (MANUFACTURING)DOP2022-09-28
00842365100540Citrine QTRAP MS/MSAB SCIEX (MANUFACTURING)DOP2022-09-28
00842365102049AB SCIEX Triple Quad™ 4500MDAB SCIEX (MANUFACTURING)DOP2022-09-28
00842365102063AB SCIEX QTRAP® 4500MDAB SCIEX (MANUFACTURING)DOP2022-09-28
05700574007300K6460 Triple Quadrupole MS – AJSAGILENT TECHNOLOGIES, INC.DOP2022-08-15
05700574007317K6460 Triple Quadrupole MS – ESIAGILENT TECHNOLOGIES, INC.DOP2022-08-15
04540217400607LCMS-8040 CLSHIMADZU CORPORATIONDOP2022-05-20
04540217400669LCMS-8045CLSHIMADZU CORPORATIONDOP2022-05-20
04540217400713APCI-8050 SETSHIMADZU CORPORATIONDOP2022-05-20
04540217400720LCMS-8050 CLSHIMADZU CORPORATIONDOP2022-05-20
04540217400744LCMS-8060 CLSHIMADZU CORPORATIONDOP2022-05-20
00816776020346XevoWATERS TECHNOLOGIES CORPORATIONDOP2021-10-06
00816776020179XevoWATERS TECHNOLOGIES CORPORATIONDOP2021-10-05
00816776020155XevoWATERS TECHNOLOGIES CORPORATIONDOP2021-10-04
00816776020162XevoWATERS TECHNOLOGIES CORPORATIONDOP2021-10-04
04540217400621LCMS-8050 CLSHIMADZU CORPORATIONDOP2020-10-28
04540217400645LCMS-8060 CLSHIMADZU CORPORATIONDOP2020-10-28
04540217400799LCMS-8040 CLSHIMADZU CORPORATIONDOP2020-10-28
00850010566023SpectroChip CPM Kit (2x96)AGENA BIOSCIENCE, INC.DOP2020-09-08
00850010566030SpectroChip CPM Kit (10x96)AGENA BIOSCIENCE, INC.DOP2020-09-08
00850010566061CalibrantAGENA BIOSCIENCE, INC.DOP2020-09-08
00850010566009MassARRAAY DxAGENA BIOSCIENCE, INC.DOP2020-09-08