Home GMDN nucleic-acid-hybridization-detection-ivd-probe Nucleic acid hybridization detection IVD, probe
Definition A defined piece(s) of nucleic acid, typically tagged with a fluorescent marker, intended to be used for the detection of a specific target nucleotide sequence at a single-gene locus or whole/partial chromosome level in a clinical specimen, in order to identify chromosomal abnormalities (e.g., aneuploidy, deletion, translocation, duplication, inversion, gene insertion). It is typically used in nucleic acid hybridization detection techniques [e.g., fluorescent in situ hybridization (FISH), chromogenic ISH (CISH)].
GUDID devices 571
Last updated 2026-08-08 10:08:40
Representative GUDID Devices# Primary DI, Brand, Company table Primary DI Brand Company Model Published B766C313150 HPV E6, E7 mRNA Probe, Ready to Use Incelldx, Inc. C31315 2023-02-28 00847627002150 RISH™ EBER Probe BIOCARE MEDICAL LLC BRA0001T 2022-12-13 00847627002167 RISH™ Kappa Light Chain DNA Probe BIOCARE MEDICAL LLC BRA0004T 2022-12-13 00847627002174 RISH™ Lambda Light Chain DNA Probe BIOCARE MEDICAL LLC BRA0005T 2022-12-13 00847627002181 RISH™ Cytomegalovirus (CMV) Probe BIOCARE MEDICAL LLC BRA0011T 2022-12-13 00847627012531 RISH™ HRP Detection Kit BIOCARE MEDICAL LLC RI0207KG 2022-12-13 00847627012555 RISH™ AP Detection Kit BIOCARE MEDICAL LLC RI0213KG 2022-12-13 00847627014566 RISH™ Retrieval 10x BIOCARE MEDICAL LLC RI0209M 2022-12-13 00847627034311 RISH™ Epstein-Barr Encoded RNA (EBER) Probe BIOCARE MEDICAL LLC OPPA0001T60 2022-12-21 M663DF3001201001 DiskFISH CELLAY, INC. DF3-0012-0100 2026-01-06 M663DF4005901001 DiskFISH CELLAY, INC. DF4-0059-0100 2026-01-06 M663DF400599 DiskFISH CELLAY, INC. DF40059 2026-01-06 M663DF4024401001 DiskFISH CELLAY, INC. DF4-0244-0100 2026-01-06 M663DF402449 DiskFISH CELLAY, INC. DF40244 2026-01-06 M663OF3001201001 OligoFISH CELLAY, INC. OF3-0012-0100 2026-01-06 M663OF3025101001 OligoFISH CELLAY, INC. OF3-0251-0100 2026-01-06 M663OF4005901001 OligoFISH CELLAY, INC. OF4-0059-0100 2026-01-06 M663OF4024401001 OligoFISH CELLAY, INC. OF4-0244-0100 2026-01-06 M663CKOF300120 OligoFISH CELLAY, INC. OF3-0012-0100 2026-01-06 M663CKOF302510 OligoFISH CELLAY, INC. OF3-0251-0100 2026-01-06 M663CKOF400590 OligoFISH CELLAY, INC. OF4-0059-0100 2026-01-06 M663CKOF402440 OligoFISH CELLAY, INC. OF4-0244-0100 2026-01-06 M663DF300120 DiskFISH CELLAY, INC. DF3-0012-0100 2026-01-06 M663DF300129 DiskFISH CELLAY, INC. DF30012 2026-01-06 M663DF400590 DiskFISH CELLAY, INC. DF40059 2026-01-06 M663DF402440 DiskFISH CELLAY, INC. DF40244 2026-01-06 M663OF4005903001 OligoFISH CELLAY, INC. OF4-0059-0300 2026-01-06 00847627034328 RISH™ Lambda Light Chain DNA Probe BIOCARE MEDICAL LLC OPPA0005T60 2023-03-01 00847627034335 RISH™ Kappa Light Chain DNA Probe BIOCARE MEDICAL LLC OPPA0004T60 2023-03-01 00847627000217 5p15.2 Red BIOCARE MEDICAL LLC CFA7251A 2022-12-07 00847627000224 5p15.2 Red BIOCARE MEDICAL LLC CFA7251X 2022-12-07 00847627000323 ATM (11q22.3) Orange BIOCARE MEDICAL LLC HFA7262A 2022-12-07 00847627000460 6q21 Green BIOCARE MEDICAL LLC HFA7309A 2022-12-07 00847627000484 ATM (11q22.3) Green BIOCARE MEDICAL LLC HFA7316A 2022-12-07 00847627000583 5p15.2 Green BIOCARE MEDICAL LLC PFA7250V 2022-12-07 00847627000590 5p15.2 Red BIOCARE MEDICAL LLC PFA7251V 2022-12-07 00847627000606 20q13.2 Orange BIOCARE MEDICAL LLC PFA7255V 2022-12-07 00847627000613 ATM (11q22.3) Aqua BIOCARE MEDICAL LLC PFA7263V 2022-12-07 00847627000675 20q13.2 Aqua BIOCARE MEDICAL LLC PFA7325V 2022-12-07 00884999012783 Vysis ABBOTT MOLECULAR INC. 05J87-001 2022-10-28 00847627000040 HPV Type 6 Probe (Digoxigenin) BIOCARE MEDICAL LLC BRA4045-0.6 2022-09-23 00847627000057 HPV Type 6 Probe (Digoxigenin) BIOCARE MEDICAL LLC BRA4045A 2022-09-23 00847627000064 HPV Type 11 Probe (Digoxigenin) BIOCARE MEDICAL LLC BRA4046-0.6 2022-09-23 00847627000071 HPV Type 11 Probe (Digoxigenin) BIOCARE MEDICAL LLC BRA4046A 2022-09-23 00847627000088 HPV Type 16 Probe (Digoxigenin) BIOCARE MEDICAL LLC BRA4047-0.6 2022-09-23 00847627000095 HPV Type 16 Probe (Digoxigenin) BIOCARE MEDICAL LLC BRA4047A 2022-09-23 00847627000101 HPV Type 18 Probe (Digoxigenin) BIOCARE MEDICAL LLC BRA4048-0.6 2022-09-23 00847627000118 HPV Type 18 Probe (Digoxigenin) BIOCARE MEDICAL LLC BRA4048A 2022-09-23 00847627000125 HPV Type 31 Probe (Digoxigenin) BIOCARE MEDICAL LLC BRA4051-0.6 2022-09-23 00847627000132 HPV Type 31 Probe (Digoxigenin) BIOCARE MEDICAL LLC BRA4051A 2022-09-23 00847627000149 HPV Type 51 Probe (Digoxigenin) BIOCARE MEDICAL LLC BRA4052-0.6 2022-09-23 00847627000156 HPV Type 51 Probe (Digoxigenin) BIOCARE MEDICAL LLC BRA4052A 2022-09-23 00847627000163 Copy Control 3 Aqua BIOCARE MEDICAL LLC CFA7164A 2022-09-23 00847627000170 Copy Control 3 Aqua BIOCARE MEDICAL LLC CFA7164Y 2022-09-23 00847627000187 Copy Control 7 Orange BIOCARE MEDICAL LLC CFA7187A 2022-09-23 00847627000194 Copy Control 7 Gold BIOCARE MEDICAL LLC CFA7188Y 2022-09-23 00847627000200 Copy Control 10 Green BIOCARE MEDICAL LLC CFA7200A 2022-09-23 00847627000231 Copy Control 3 Aqua BIOCARE MEDICAL LLC HFA7164A 2022-09-23 00847627000248 Copy Control 4q12 Green BIOCARE MEDICAL LLC HFA7168A 2022-09-23 00847627000255 Copy Control 4q12 Aqua BIOCARE MEDICAL LLC HFA7169A 2022-09-23 00847627000262 Copy Control 10 Green BIOCARE MEDICAL LLC HFA7200A 2022-09-23 00847627000279 Copy Control 12 Green BIOCARE MEDICAL LLC HFA7210A 2022-09-23 00847627000286 Copy Control 12 Aqua BIOCARE MEDICAL LLC HFA7211A 2022-09-23 00847627000293 Copy Control 17 Green BIOCARE MEDICAL LLC HFA7225A 2022-09-23 00847627000309 Copy Control 17 Aqua BIOCARE MEDICAL LLC HFA7226A 2022-09-23 00847627000316 CCND1 (11q13) Orange BIOCARE MEDICAL LLC HFA7260A 2022-09-23 00847627000330 D13S25 (13q14.3) Orange BIOCARE MEDICAL LLC HFA7266A 2022-09-23 00847627000347 D13S319 (13q14.2) Orange BIOCARE MEDICAL LLC HFA7267A 2022-09-23 00847627000354 FGFR3 (4p16.3) Aqua BIOCARE MEDICAL LLC HFA7276A 2022-09-23 00847627000361 FGFR3 (4p16.3) Orange BIOCARE MEDICAL LLC HFA7277A 2022-09-23 00847627000378 IGH (14q32) Constant Orange BIOCARE MEDICAL LLC HFA7278A 2022-09-23 00847627000385 IGH (14q32) Variable Green BIOCARE MEDICAL LLC HFA7279A 2022-09-23 00847627000392 LAMP1 (13q34) Green BIOCARE MEDICAL LLC HFA7281A 2022-09-23 00847627000408 LAMP1 (13q34) Aqua BIOCARE MEDICAL LLC HFA7282A 2022-09-23 00847627000415 MYB (6q23) Orange BIOCARE MEDICAL LLC HFA7283A 2022-09-23 00847627000422 RB1 (13q14.2) Orange BIOCARE MEDICAL LLC HFA7298A 2022-09-23 00847627000439 TP53 (17p13) Orange BIOCARE MEDICAL LLC HFA7306A 2022-09-23 00847627000446 1p21.2 Green BIOCARE MEDICAL LLC HFA7307A 2022-09-23 00847627000453 1q21.3 Orange BIOCARE MEDICAL LLC HFA7308A 2022-09-23 00847627000477 RB1 (13q14.2) Green BIOCARE MEDICAL LLC HFA7315A 2022-09-23