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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
4,644
Last updated
2026-07-17 22:00:00

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
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
00850078606143New Life DiagnosticsNEW LIFE DIAGNOSTICS LLCAscaris IgM ELISA Kit2026-04-16
00850078606174New Life DiagnosticsNEW LIFE DIAGNOSTICS LLCCysticercosis IgM (T. solium) ELISA Kit2026-04-16
00850078606181New Life DiagnosticsNEW LIFE DIAGNOSTICS LLCGnathostoma IgG ELISA Kit2026-04-16
00850078606198New Life DiagnosticsNEW LIFE DIAGNOSTICS LLCAngiostrongylus IgM ELISA Kit2026-04-16
00850078606204New Life DiagnosticsNEW LIFE DIAGNOSTICS LLCParagonimus IgM ELISA Kit2026-04-16
00850078606211New Life DiagnosticsNEW LIFE DIAGNOSTICS LLCClonorchis IgM ELISA Kit2026-04-16
00850078606266New Life DiagnosticsNEW LIFE DIAGNOSTICS LLCStrongyloides IgM ELISA Kit2026-04-16
00850078606273New Life DiagnosticsNEW LIFE DIAGNOSTICS LLCToxocara IgM ELISA Kit2026-04-16
00850078606303New Life DiagnosticsNEW LIFE DIAGNOSTICS LLCAngiostrongylus IgG ELISA Kit2026-04-16
00850078606310New Life DiagnosticsNEW LIFE DIAGNOSTICS LLCClonorchis IgG ELISA Kit2026-04-16
00850078606327New Life DiagnosticsNEW LIFE DIAGNOSTICS LLCParagonimus IgG ELISA Kit2026-04-16
00850078606358New Life DiagnosticsNEW LIFE DIAGNOSTICS LLCFilariasis IgM ELISA Kit2026-04-16
00850078606372New Life DiagnosticsNEW LIFE DIAGNOSTICS LLCAncylostoma IgG ELISA Kit2026-04-16
00850078606389New Life DiagnosticsNEW LIFE DIAGNOSTICS LLCAncylostoma IgM ELISA Kit2026-04-16
00850078606396New Life DiagnosticsNEW LIFE DIAGNOSTICS LLCGnathostoma IgM ELISA Kit2026-04-16
03661540952531DSQ Alert Candida auris Primer Mix ASRElitechgroup Mdx LLC8007292022-12-12
03661540952548DSQ Alert Candida auris Probe Mix ASRElitechgroup Mdx LLC8007302022-12-12
04251315800960MetaSystems ProbesMetaSystems Probes GmbHD-0823-500-FI2025-10-14
04251315800977MetaSystems ProbesMetaSystems Probes GmbHD-0824-500-BL2025-10-14
04251315801097MetaSystems ProbesMetaSystems Probes GmbHD-5131-999-OG2025-11-21
04251315801103MetaSystems ProbesMetaSystems Probes GmbHD-5136-999-OG2025-11-21
04251315801189MetaSystems ProbesMetaSystems Probes GmbHD-0816-050-FI2026-03-27
04251315801257MetaSystems ProbesMetaSystems Probes GmbHD-0816-050-OR2026-03-27
04251315801264MetaSystems ProbesMetaSystems Probes GmbHD-5139-999-OG2026-04-08
04251315801271MetaSystems ProbesMetaSystems Probes GmbHD-5141-999-OG2026-04-08
05055844934603CytoCell myProbesCYTOCELL LIMITEDMPD41022025-05-22
05055844934610CytoCell myProbesCYTOCELL LIMITEDMPP04212025-05-22
05055844934627CytoCell myProbesCYTOCELL LIMITEDMPH512112025-05-22
05055844934634CytoCell myProbesCYTOCELL LIMITEDMPH512122025-05-22
05055844934641CytoCell myProbesCYTOCELL LIMITEDMPH512132025-05-22
05055844934658CytoCell myProbesCYTOCELL LIMITEDMPH07612025-05-22
05055844934665CytoCell myProbesCYTOCELL LIMITEDMPD33212025-05-22
05055844934672CytoCell myProbesCYTOCELL LIMITEDMPD33222025-05-22
05055844934689CytoCell myProbesCYTOCELL LIMITEDMPD33232025-05-22
05055844934696CytoCell myProbesCYTOCELL LIMITEDMPD209422025-05-22
05055844934702CytoCell myProbesCYTOCELL LIMITEDMPH231222025-05-22
05055844934757CytoCell myProbesCYTOCELL LIMITEDMPP163012025-06-24