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Assay development analyte-specific reagent IVD

Definition
An antibody, specific receptor protein, ligand, nucleic acid sequence (e.g., primer, probe) or similar reagent, which through specific binding or chemical reaction with an intended target, is used to identify or quantify a chemical substance in a biological specimen for the development of a laboratory developed test (LDT) or commercial in vitro diagnostic medical device (IVD). Commonly referred to as an analyte specific reagent (ASR), it is neither labelled with instructions for use nor diagnostic or performance claims.
GUDID devices
4,674
Last updated
2026-10-04 01:48:29

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00382906718198HorizonBecton, Dickinson And Company6718192026-09-24
00382906718372HorizonBecton, Dickinson And Company6718372026-09-24
05056336800635Biochrom EZ Nin Reagent Kit 8L NCBIOCHROM LIMITED80-6003-142023-07-14
00810034704399FITC anti-human Ki-67BIOLEGEND, INC.9899582026-09-04
00810034704481PE anti-human CD366BIOLEGEND, INC.9899642026-09-04
00810034703170PerCP anti-human CD61BIOLEGEND, INC.9880042026-08-07
00810034704252FITC anti-human TNF-AlphaBIOLEGEND, INC.9868082026-07-28
00810034704320PE anti-human IL-2BIOLEGEND, INC.9899462026-07-28
00810227730211Fort Worth DiagnosticsFort Worth Diagnostics, LLCMIY0032026-07-24
00850051429820Fort Worth DiagnosticsFort Worth Diagnostics, LLCANA0012026-07-24
00850051429837Fort Worth DiagnosticsFort Worth Diagnostics, LLCBAB0012026-07-24
00850051429844Fort Worth DiagnosticsFort Worth Diagnostics, LLCEHR0012026-07-24
00850051429851Fort Worth DiagnosticsFort Worth Diagnostics, LLCMIY0012026-07-24
00810227730006Fort Worth DiagnosticsFort Worth Diagnostics, LLCLPNE0022026-07-22
00810227730013Fort Worth DiagnosticsFort Worth Diagnostics, LLCBGLO0022026-07-22
00810227730020Fort Worth DiagnosticsFort Worth Diagnostics, LLCLSPP0032026-07-22
00810227730037Fort Worth DiagnosticsFort Worth Diagnostics, LLCLPNE0032026-07-22
00850051429967Fort Worth DiagnosticsFort Worth Diagnostics, LLCLSPP0012026-07-22
00850051429974Fort Worth DiagnosticsFort Worth Diagnostics, LLCLPNE0012026-07-22
00850051429981Fort Worth DiagnosticsFort Worth Diagnostics, LLCBGLO0012026-07-22
00850051429998Fort Worth DiagnosticsFort Worth Diagnostics, LLCLSPP0022026-07-22
00810227730044Fort Worth DiagnosticsFort Worth Diagnostics, LLCPJP0012026-07-21
00810227730051Fort Worth DiagnosticsFort Worth Diagnostics, LLCPJP0022026-07-21
00810227730068Fort Worth DiagnosticsFort Worth Diagnostics, LLCPJP0032026-07-21
00810227730136Fort Worth DiagnosticsFort Worth Diagnostics, LLCCOCC0022026-07-21
00810227730143Fort Worth DiagnosticsFort Worth Diagnostics, LLCCIMM0022026-07-21
00810227730150Fort Worth DiagnosticsFort Worth Diagnostics, LLCCPOS0022026-07-21
00810227730228Fort Worth DiagnosticsFort Worth Diagnostics, LLCRSV0012026-07-21
00850051429004Fort Worth DiagnosticsFort Worth Diagnostics, LLCBAB0012024-02-16
00850051429028Fort Worth DiagnosticsFort Worth Diagnostics, LLCANA0012024-01-23
00850051429035Fort Worth DiagnosticsFort Worth Diagnostics, LLCBOR0012024-02-29
00850051429042Fort Worth DiagnosticsFort Worth Diagnostics, LLCEHR0012024-03-01
00850051429363Fort Worth DiagnosticsFort Worth Diagnostics, LLCMIY0012024-05-18
05055844935792CytoCell myProbesCYTOCELL LIMITEDMPA602512026-07-19
00850051429219Fort Worth DiagnosticsFort Worth Diagnostics, LLCRSV0012024-03-01
00810227730198Fort Worth DiagnosticsFort Worth Diagnostics, LLCH5N10052026-07-13
00810227730204Fort Worth DiagnosticsFort Worth Diagnostics, LLCFLUA0052026-07-13
15099590807160Anti-TCR Cß1 (TRBC1)-FITCIMMUNOTECHD328292026-06-25
00810034704306Spark Violet™ 538 anti-human CD4BIOLEGEND, INC.9808262026-07-06
00810034704337Spark Violet™ 423 anti-human CD45BIOLEGEND, INC.9823262026-07-06
00810034704085FITC anti-human Granzyme BBIOLEGEND, INC.9899242026-06-05
00810034704146PE/Cyanine7 anti-human Granzyme BBIOLEGEND, INC.9899262026-06-05
00810034704160APC anti-human CD64BIOLEGEND, INC.9832162026-06-05
00810034704177FITC anti-human CD69BIOLEGEND, INC.9852082026-06-05
00810034704191PE/Cyanine7 anti-human CD69BIOLEGEND, INC.9852102026-06-05
00810034704214APC anti-human CD31BIOLEGEND, INC.9890042026-06-05
00810034704245APC anti-human CD274BIOLEGEND, INC.9899422026-06-05
00810034704290APC/Fire™ 750 anti-human CD69BIOLEGEND, INC.9852142026-06-05
05055844935761CytoCell myProbesCYTOCELL LIMITEDMPD65712026-06-06
05055844935778CytoCell myProbesCYTOCELL LIMITEDMPD65722026-06-06
00810034702951PerCP/Cyanine5.5 anti-human Beta2-microglobulinBIOLEGEND, INC.9878022026-06-01
00810034704061PE/Dazzle™ 594 anti-human CD22BIOLEGEND, INC.9876062026-06-01
00810034704092FITC anti-human CD35BIOLEGEND, INC.9899282026-06-01
00810034704108PE/Cyanine7 anti-human CD22BIOLEGEND, INC.9876082026-06-01
00810034704139PE/Cyanine7 anti-human CD300eBIOLEGEND, INC.9899302026-06-01
00358468000019ALDURAZYME 2.9 MG/5ML MEDSU VL1 DIAG USGENZYME CORPORATION7626182020-06-01
00358468000026MYOZYME 50MG/10ML MEDSU VL1 DIAG USGENZYME CORPORATION7626192020-06-01
00358468000033FABRAZYME 35MG/7ML VL1 DIAG USGENZYME CORPORATION7626202020-06-01
00358468000040CEREZYME 400IU MEDSU VL1 DIAG USGENZYME CORPORATION7626212020-06-01
00810034702388PE anti-human CD99BIOLEGEND, INC.9862022022-12-12
00810034702418APC anti-human CD79bBIOLEGEND, INC.9861042022-12-12
00810034702432PE anti-human CD45BIOLEGEND, INC.9823222023-01-30
00810034702449PE anti-human CD45ROBIOLEGEND, INC.9831042022-12-12
00810034702463PerCP/Cyanine5.5 anti-human CD13BIOLEGEND, INC.9828122023-01-30
00810034702470PerCP/Cyanine5.5 anti-human CD79b BIOLEGEND, INC.9861062023-01-30
00810034703477FITC anti-human CD94BIOLEGEND, INC.9811042024-09-05
00810034703491FITC anti-human CD31 BIOLEGEND, INC.9890022024-09-05
00810034703507FITC anti-human CD19 BIOLEGEND, INC.9824202024-09-05
00810034703521FITC anti-human Ig light chain LambdaBIOLEGEND, INC.9885082024-09-05
00810034703859PE anti-human TCR Gamma/DeltaBIOLEGEND, INC.9899042025-10-23
00810034703910PE/Cyanine7 anti-human IFN-GammaBIOLEGEND, INC.9867062025-10-06
00810034703934PE anti-human CD73BIOLEGEND, INC.9899142025-10-06
00810034703958Spark Violet™ 423 anti-human CD71BIOLEGEND, INC.9851102025-10-23
00810034703972APC anti-human Granzyme BBIOLEGEND, INC.9899122025-10-06
00810034703996PE anti-human CD22BIOLEGEND, INC.9876042025-10-06
00850051429738Fort Worth DiagnosticsFort Worth Diagnostics, LLCEV0042025-10-28
00850051429745Fort Worth DiagnosticsFort Worth Diagnostics, LLCPEV0042025-10-28
00850051429752Fort Worth DiagnosticsFort Worth Diagnostics, LLCHHV60022025-10-28
00850051429769Fort Worth DiagnosticsFort Worth Diagnostics, LLCJCV0012025-10-28
00850078606068New Life DiagnosticsNEW LIFE DIAGNOSTICS LLCLeishmania IgG ELISA Kit2026-04-16