FDA.reportPublic FDA data

HPLC Cartridge (iHPLC)

Primary DI
07613336228630
Brand
HPLC Cartridge (iHPLC)
Company
Roche Diagnostics GmbH
Model
09511725190
Catalog number
09511725190
Published
2025-07-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DPMCOLUMNS, LIQUID CHROMATOGRAPHY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DPMColumns, Liquid ChromatographyClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613336228630PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613336228630076133362286307613336228630

GMDN Terms#

Term, Definition table
TermDefinition
High performance liquid chromatography analyser column IVDA component of a high performance liquid chromatograph (HPLC) analyser that functions as a narrow flow-through tube through which different chemical constituents of a sample pass in a high pressure liquid stream at different rates, depending on their various chemical and physical properties and their interaction with a specific column filling. The internal diameter of the HPLC tubing (typically ranges from under 0.3 mm to greater than 10 mm) determines the quantity of analyte that can be loaded and analyser sensitivity. The tubes are made of various materials including stainless steel and fused silica.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315028860
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613336234457PreciControl Syphilis09465022190094650221902026-05-15
04015630913893AMYP Amylase EPS Pancreatic20766623322207666233222016-09-20
04015630910991alpha-Amylase liquid acc. to IFCC11876473316118764733162016-09-20
04015630911004Pancreatic alpha-amylase liquid11876562316118765623162016-09-20
04015630926848alpha-Amylase EPS Pancreatic540177119054017711902016-09-20
07613336121016a-Amylase EPS Pancreatic08056820190080568201902020-03-05
07613336171509Elecsys Calcitonin09005676190090056761902026-06-01
07613336171516CalSet Calcitonin09005684190090056841902026-06-01
07613336188064Elecsys Calcitonin09005668160090056681602026-06-01
07613336217641Elecsys Anti-TSHR09744819190097448191902026-06-01
07613336218341Elecsys CA 19-909755608190097556081902026-06-01
07613336218389Elecsys Estradiol III09755659190097556591902026-06-01
07613336235546PreciControl HIV Gen II09465006160094650061602026-05-22
07613336231432Tina-quant Antistreptolysin-O II09537368190095373681902026-05-08
07613336231449Tina-quant Antistreptolysin-O II09537341190095373411902026-05-08
07613336154342Elecsys Anti-HBc IgM11820567160118205671602017-09-29
07613336217832Elecsys Testosterone II09745963190097459631902026-04-21
07613336153932Elecsys Anti-HBc IgM07026811160070268111602018-03-19
00875197004748cobas® HBV/HCV/HIV-1 Control Kit1.0069988871902015-12-04
07613336203606Elecsys Anti-HBc II09014918160090149181602022-04-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336228647Rapid Cartridge B (iRapidB)Roche Diagnostics GmbHDPM2025-07-31
07613336228654Rapid Cartridge C (iRapidC)Roche Diagnostics GmbHDPM2025-07-31
00816776020292MassTrakWATERS TECHNOLOGIES CORPORATIONDPM2022-02-15
00816776020193AcquityWATERS TECHNOLOGIES CORPORATIONDPM2021-10-06
00816776020209AcquityWATERS TECHNOLOGIES CORPORATIONDPM2021-10-06
00816776020216AcquityWATERS TECHNOLOGIES CORPORATIONDPM2021-10-06
00816776020223AcquityWATERS TECHNOLOGIES CORPORATIONDPM2021-10-06
00816776020186AcquityWATERS TECHNOLOGIES CORPORATIONDPM2021-10-05
00816776020018MassTrak™WATERS TECHNOLOGIES CORPORATIONDPM2016-09-24