FDA.reportPublic FDA data

Multiple-type clinical chemistry analyte profile IVD, control

Definition
A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of multiple types of clinical chemistry analytes (e.g., combination of electrolytes, hormones, and proteins) in a clinical specimen, which contribute to or create a full general biochemistry profile.
GUDID devices
2,918
Last updated
2026-09-04 23:11:29

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
B085K0311100Audit MicroControls Control FD Assayed Chemistry Level 1AALTO SCIENTIFICK0311-102018-03-27
B085K0312100Audit MicroControls Control FD Assayed Chemistry Level 2AALTO SCIENTIFICK0312-102018-03-27
B800BUS1DPFEUH0BUSULFAN LEVEL 1UTAK LABORATORIES, INC.BUS 1 DP F EUH2026-08-26
B800BUS2DPFEUH0BUSULFAN LEVEL 2UTAK LABORATORIES, INC.BUS 2 DP F EUH2026-08-26
B800BUS3DPFEUH0BUSULFAN LEVEL 3UTAK LABORATORIES, INC.BUS 3 DP F EUH2026-08-26
B800BUS4DPFEUH0BUSULFAN LEVEL 4UTAK LABORATORIES, INC.BUS 4 DP F EUH2026-08-26
B800BUS5DPFEUH0BUSULFAN LEVEL 5UTAK LABORATORIES, INC.BUS 5 DP F EUH2026-08-26
B800BUS6DPFEUH0BUSULFAN LEVEL 6UTAK LABORATORIES, INC.BUS 6 DP F EUH2026-08-26
10673486014112Teco Diagnostics TC-TROL (N) Serum Control Level I HumanTECO DIAGNOSTICSTCTROL-N2026-08-25
10673486014129Teco Diagnostics TC-TROL (A) Serum Control Level II HumanTECO DIAGNOSTICSTCTROL-A2026-08-25
00628063400454DC-TROL Level 1Sekisui Diagnostics, LLCSM-0522016-09-20
00628063400461DC-TROL Level 2Sekisui Diagnostics, LLCSM-0562016-09-20
00628063401222DC-TROL LEVELS 1 & 2Sekisui Diagnostics, LLCSM-0572020-03-30
05391523442831Multichem AETECHNO-PATH MANUFACTURING LIMITED06S78612026-06-02
05391523442848Multichem AETECHNO-PATH MANUFACTURING LIMITED06S78622026-06-02
05391523442855Multichem AETECHNO-PATH MANUFACTURING LIMITED06S78632026-06-02
05391523442862Multichem IA SpecialityTECHNO-PATH MANUFACTURING LIMITED06S78312026-06-02
05391523442879Multichem IA SpecialityTECHNO-PATH MANUFACTURING LIMITED06S78322026-06-02
05391523442886Multichem IA SpecialityTECHNO-PATH MANUFACTURING LIMITED06S78332026-06-02
05391523442893Multichem CSFTECHNO-PATH MANUFACTURING LIMITED06S78012026-06-02
05391523442909Multichem CSFTECHNO-PATH MANUFACTURING LIMITED06S78022026-06-02
05391523442916Multichem NBTECHNO-PATH MANUFACTURING LIMITED06S78802026-06-02
05391523442923Multichem D-DimerTECHNO-PATH MANUFACTURING LIMITED06S78912026-06-02
05391523442930Multichem D-DimerTECHNO-PATH MANUFACTURING LIMITED06S78922026-06-02
00884883009080MAS Immunology Advanced Sample PackMicrogenics CorporationICA-S12026-05-27
00884883011373MAS Immunology Advanced Level 1Microgenics CorporationICA-1012026-05-27
00884883011380MAS Immunology Advanced Level 2Microgenics CorporationICA-2022026-05-27
00884883011397MAS Immunology Advanced Level 3Microgenics CorporationICA-3032026-05-27
00850011135501VALIDATELgc Clinical Diagnostics, Inc.402pf2022-11-01
00850011135822VALIDATELgc Clinical Diagnostics, Inc.602ab2025-10-08
00850011135839VALIDATELgc Clinical Diagnostics, Inc.603ab2025-10-08
00852676007087Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.PH50412023-08-09
00852676007094Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.PH50422023-08-09
00852676007100Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.PH50202023-08-09
04015630930593PreciControl Lp(a) Gen.2Roche Diagnostics GmbH058526501902025-05-27
05204309116010Clinical Chemistry Control Lev1MEDICON HELLAS S.A.1578-0901-12 2026-04-27
05204309116027Clinical Chemistry Control Lev2MEDICON HELLAS S.A.1578-0902-12 2026-04-27
05391523440073Multichem UTECHNO-PATH MANUFACTURING LIMITED05P80-102022-09-16
05391523440080Multichem WBTTECHNO-PATH MANUFACTURING LIMITED05P77-102022-09-16
05391523440097Multichem PTECHNO-PATH MANUFACTURING LIMITED05P81-102022-09-15
05391523440110Multichem NBTECHNO-PATH MANUFACTURING LIMITEDNB800X2022-09-16
05391523440127Multichem hsTnTECHNO-PATH MANUFACTURING LIMITEDHS301X2022-09-16
05391523440134Multichem AETECHNO-PATH MANUFACTURING LIMITEDAE600X2022-09-16
05391523440141MultiCHECK CardiacTECHNO-PATH MANUFACTURING LIMITED944-5132022-09-16
05391523440158MultiCHECK CardiacTECHNO-PATH MANUFACTURING LIMITED944-5142022-09-16
05391523440165MultiCHECK CardiacTECHNO-PATH MANUFACTURING LIMITED944-5152022-09-16
05391523440172Multichem NBTECHNO-PATH MANUFACTURING LIMITEDNB800A2022-09-16
05391523440189Multichem hsTnTECHNO-PATH MANUFACTURING LIMITEDHS301A2022-09-16
05391523440202Multichem A1cTECHNO-PATH MANUFACTURING LIMITEDHB000A2022-09-16
05391523440219Multichem WBTTECHNO-PATH MANUFACTURING LIMITEDWB000X2022-09-16
05391523440233Multichem WBTTECHNO-PATH MANUFACTURING LIMITEDWB000A2022-09-15
05391523440240Multichem PTECHNO-PATH MANUFACTURING LIMITEDSP40PX2022-09-16
05391523440257Multichem PTECHNO-PATH MANUFACTURING LIMITEDSP41PA2022-09-15
05391523440387Multichem UTECHNO-PATH MANUFACTURING LIMITEDUC201X2022-09-16
05391523440394Multichem UTECHNO-PATH MANUFACTURING LIMITEDUC202X2022-09-16
05391523440417Multichem UTECHNO-PATH MANUFACTURING LIMITEDUC201A.102022-09-16
05391523440424Multichem UTECHNO-PATH MANUFACTURING LIMITEDUC202A.102022-09-16
05391523440684Multichem AETECHNO-PATH MANUFACTURING LIMITEDAE600A2022-09-16
05391523440752Multichem UTECHNO-PATH MANUFACTURING LIMITED08P89-102022-09-16
05391523440769Multichem PTECHNO-PATH MANUFACTURING LIMITED08P90-102022-09-16
05391523440837Multichem A1cTECHNO-PATH MANUFACTURING LIMITEDHB001A2022-09-16
05391523440844Multichem A1cTECHNO-PATH MANUFACTURING LIMITEDHB002A2022-09-16
05391523440851Multichem A1cTECHNO-PATH MANUFACTURING LIMITEDHB000M2022-09-16
05391523440943Multichem CSFTECHNO-PATH MANUFACTURING LIMITEDCF102A2022-09-16
05391523440950Multichem IA SpecialityTECHNO-PATH MANUFACTURING LIMITEDBP300X2022-09-16
05391523440967Multichem IA SpecialityTECHNO-PATH MANUFACTURING LIMITEDBP301X2022-09-16
05391523440974Multichem IA SpecialityTECHNO-PATH MANUFACTURING LIMITEDBP302X2022-09-16
05391523440981Multichem IA SpecialityTECHNO-PATH MANUFACTURING LIMITEDBP303X2022-09-16
05391523440998Multichem IA SpecialityTECHNO-PATH MANUFACTURING LIMITEDBP300A2022-09-16
05391523441001Multichem IA SpecialityTECHNO-PATH MANUFACTURING LIMITEDBP301A2022-09-16
05391523441018Multichem IA SpecialityTECHNO-PATH MANUFACTURING LIMITEDBP302A2022-09-16
05391523441025Multichem IA SpecialityTECHNO-PATH MANUFACTURING LIMITEDBP303A2022-09-16
05391523441087Multichem AETECHNO-PATH MANUFACTURING LIMITEDAE610A2022-09-16
05391523441094Multichem AETECHNO-PATH MANUFACTURING LIMITEDAE611A2022-09-16
05391523441100Multichem AETECHNO-PATH MANUFACTURING LIMITEDAE612A2022-09-16
05391523441117Multichem AETECHNO-PATH MANUFACTURING LIMITEDAE613A2022-09-16
05391523441124Multichem AETECHNO-PATH MANUFACTURING LIMITEDAE610X2022-09-16
05391523441131Multichem AETECHNO-PATH MANUFACTURING LIMITEDAE611X2022-09-16
05391523441148Multichem AETECHNO-PATH MANUFACTURING LIMITEDAE612X2022-09-16
05391523441155Multichem AETECHNO-PATH MANUFACTURING LIMITEDAE613X2022-09-16