FDA.reportPublic FDA data

SpectroChip CPM Kit (2x96)

Primary DI
00850010566023
Brand
SpectroChip CPM Kit (2x96)
Company
AGENA BIOSCIENCE, INC.
Model
10610F
Catalog number
10610F
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
00850010566023PrimaryGS10
10850010566020Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850010566023008500105660238500105660230850010566023
1085001056602010850010566020

GMDN Terms#

Term, Definition table
TermDefinition
Mass spectrometry specimen target holderA supportive device intended to hold a mass spectrometry specimen target (e.g., MALDI plate) in order to facilitate positioning and ensure correct electrical contact of the target in the mass spectrometry analyser during analysis. This is a reusable device.

Contacts#

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

Regulatory Flags#

DUNS number
079436896
Device count
2
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
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
00850010566054MassARRAY Clean Resin 28g804080402020-09-08
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
00850010566030SpectroChip CPM Kit (10x96)AGENA BIOSCIENCE, INC.DOP2020-09-08
00850010566061CalibrantAGENA BIOSCIENCE, INC.DOP2020-09-08
00850010566009MassARRAAY DxAGENA BIOSCIENCE, INC.DOP2020-09-08
00850010566016CPM DxAGENA BIOSCIENCE, INC.DOP2020-09-08