FDA Registration
Active
🇺🇸 United States
Anti-Helicobecler Pylori
Reg #: 3008776165
·
FEI: 2936532
·
Expires 2025
Products
1
Proprietary Names
647
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- BIOGENEX LABORATORIES INC.
- Registration Number
- 3008776165
- FEI Number
- 2936532
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 48810 Kato Road,Suite 100E&200E
- City
- Fremont
- State
- CA
- ZIP
- 94538
- Country
- US
Owner / Operator
- Firm Name
- BIOGENEX LABORATORIES INC.
- Operator Number
- 2936532
- Address
- 48810 Kato Road,Suite 100E&200E, --
- City
- Fremont
- State
- CA
- Postal Code
- 94538
- Country
- US
- Correspondent
- KRISHAN L KALRA
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Reagents, Specific, Analyte | MVU | Class 1 | Pathology | No | 1999-03-03 |
Proprietary Names
Anti-Helicobecler Pylori
ANTI-CYTOMEGALOVIRUS
EBER Probe
Anti-EGFR
Anti-Androgen Receptor
NEG. RB
Kappa Probe
NEG. CYC D1
Anti-Estrogen Receptor-alpha
ANTI-HEPATITIS B
OLIGO d (T) PROBE NEGATIVE PROBE
Anti-HPV-16
NEG. LAMBDA
NEG. EBER
NEG, KAPPA
Anti-P504S
Anti-Adenovirus
Alu II Probe
Anti-HSV I
Anti-EBV
Anti-c-erbB-2(Her-2/neu)
ALU PROBE II
Anti-ErbB-2/Her-2
Anti-PR
Anti-HSV II
Lamda Probe
eFISH CMYC/IGH Dual Color Dual Fusion Probe
Hsa-miR-30e
Hsa-miR-141
ANTI-Toxoplasma
Hsa-miR-144
Hsa-miR-641
Hsa-miR-182
Anti-EGFR(Pan)
Hsa-miR-378a
Hsa-miR-155
Hsa-miR-224
Hsa-miR-331-3p
Hsa-miR-let-7a
Hsa-miR-1
Hsa-miR-17
eFISH COL1A1 Dual Color Break Apart Probe
eFISH VHL/CEN 3 Dual Color Probe
eFISH TERT/5q31 Dual Color Probe
Hsa-miR-126
eFISH CHOP Dual Color Break Apart Probe
eFISH CCND1 Dual Color Break Apart Probe
eFISH MDM2/CEN 12 Dual Color Probe
Hsa-miR-100
eFISH SYT Dual Color Break Apart Probe
Hsa-miR-30c
Hsa-miR-19b
eFISH 4p11 Probe
eFISH CEN X/Yq12 Dual Color Probe
Hsa-miR-135a Probe
Hsa-miR-143
eFISH COL1A1/PDGFB Dual Color Dual Fusion Probe
eFISH EWSR1 Dual Color Break Apart Probe
eFISH CCND1/CEN 11 Dual Color Probe
Hsa-miR-203-3p
eFISH IGH Dual Color Break Apart Probe
eFISH PDGFB Dual Color Break Apart Probe
Hsa-miR-204
Hsa-miR-205
Hsa-miR-9500 Probe
Hsa-miR-133b Probe
eFISH RB1/13q12 Dual Color Probe
eFISH FGFR2/CEN 10 Dual Color Probe
Hsa-miR-125b
eFISH EGFR/CEN 7 Dual Color Probe
Hsa-miR-192 Probe
Hsa-miR-802 Probe
eFISH D13S319/13q34/CEN 12 Triple Color Probe
Hsa-miR-15a Probe
Lambda Probe for Xmatrx
Hsa-miR-410 Probe
Hsa-miR-375
eFISH FGFR1/CEN 8 Dual Color Probe
Hsa-miR-23b
Hsa-miR-let-7c
Hsa-miR-221-3p
eFISH CMYC/CEN 8 Dual Color Probe
Hsa-miR-27b
Hsa-miR-19a Probe
Hsa-miR-373 Probe
Hsa-miR-429 Probe
eFISH 13q12 Probe
eFISH 19q13/19p13 Dual Color Probe
eFISH ETV6/RUNX1 Dual Color Dual Fusion Probe
Hsa-miR-505
eFISH CEN Yq12 Probe
Hsa-miR-214 Probe
eFISH 1p12 Probe
Hsa-miR-181a Probe
Hsa-miR-22 Probe
Hsa-miR-194 Probe
Hsa-miR-215 Probe
Hsa-miR-494 Probe
Hsa-miR025 Probe
Hsa-miR-7e
Hsa-miR-610 Probe
Retinoblastoma Probe
Hsa-miR-200b
Hsa-miR-216a
Hsa-miR-18a
Hsa-miR-328
Hsa-miR-148b Probe
Hsa-miR-28-3P Probe
Hsa-miR-127-3p Probe
Hsa-miR-107 Probe
Hsa-miR-133a Probe
Hsa-miR-206 Probe
Hsa-miR-28-5P Probe
Hsa-miR-142-3P Probe
Hsa-miR-024-3P Probe
Hsa-miR-329 Probe
Hsa-miR-627 Probe
Hsa-miR-365A-3P Probe
Hsa-miR-335
Hsa-miR-222
eFISH EGR1/5p15 Dual Color Probe
eFISH AML1/ETO Dual Color Dual Fusion Probe
eFISH 1p36/1q25 Dual Color Probe
Hsa-miR-10b
Hsa- miR-9
eFISH ROS1 Dual Color Break Apart Probe
eFISH 2q11 Probe
Hsa-miR-124 Probe
eFISH CEN 11 Probe
Hsa-miR-622 Probe
eFISH RET Dual Color Break Apart Probe
Hsa-miR-615
eFISH BCL2/IGH Dual Color Dual Fusion Probe
eFISH CEN 17/HER2 Dual Color Probe
eFISH BIRC3/MALT1 Dual Color Dual Fusion Probe
eFISH PML/RARA Dual Color Dual Fusion Probe
Hsa-miR-483a
Hsa-miR-650 Probe
Hsa-miR-297 Probe
Hsa-miR-212 Probe
Hsa-miR-138 Probe
eFISH ALK Dual Color Break Apart Probe
Hsa-miR-199a
eFISH NMYC/2q11 Dual Color Probe
Hsa-miR-151a-3p
Hsa-miR-200c
Hsa-miR-101-3p
Hsa-miR-423-3p
eFISH TP53/CEN 17 Dual Color Probe
Hsa-miR-422a
eFISH BCR/ABL Dual Color Dual Fusion Probe
Hsa-miR-708
Hsa-miR-let-7e
eFISH FUS Dual Color Break Apart Probe
eFISH CMYC Dual Color Break Apart Probe
Hsa-miR-106a
eFISH TFE3 Dual Color Break Apart Probe
eFISH 21q22 Probe
eFISH BCL6 Dual Color Break Apart Probe
Hsa-miR-148a Probe
Hsa-miR-21-3p
Hsa-miR-29c
Hsa-miR-146a
eFISH PIK3CA/CEN 3 Dual Color Probe
Hsa-miR-1285
Hsa-miR-196a
eFISH p16/CEN 9 Dual Color Probe
Hsa-miR-152
Hsa-miR-26b Probe
eFISH CEN 8 Probe
Hsa-miR-630 Probe
Hsa-miR-218
Hsa-miR-17-3p
Hsa-miR-96
Hsa-miR-629
Hsa-miR-625 Probe
eFISH CEN 3 Probe
eFISH CEN 18 Probe
Hsa-miR-181b Probe
eFISH CEN 10 Probe
Hsa-miR-545-5P Probe
Hsa-miR-34a Probe
eFISH PDGFRB Dual Color Break Apart Probe
Hsa-miR-1181 Probe
Hsa-miR-27a
Hsa-miR-147b
eFISH CCND1/IGH Dual Color Dual Fusion Probe
Hsa-miR-181c Probe
Hsa-miR-412 Probe
Hsa-miR193A-3P Probe
Hsa-miR-224 Probe
Hsa-miR-153 Probe
Hsa-miR-20a Probe
Hsa-miR217 Probe
eFISH MLL Dual Color Break Apart Probe
Hsa-miR-98 Probe
Hsa-miR-15b Probe
Hsa-miR-100 Probe
Hsa-miR-let-7d Probe
Hsa-miR-198b-3p
Hsa-miR-26a Probe
Hsa-miR185 Probe
Hsa-miR-99a Probe
Hsa-miR-187 Probe
Hsa-miR381 Probe
eFISH CEN X Probe
Hsa-miR-544 Probe
eFISH CEN 12 Probe
Hsa-miR-383
Hsa-miR-449a Probe
Hsa-miR-1826 Probe
Hsa-miR-31 Probe
eFISH CEN 17 Probe
Hsa-miR-361 Probe
Hsa-miR-149 Probe
Hsa-miR-663a Probe
Hsa-miR-92a Probe
Hsa-miR-195 Probe
Hsa-miR-99b Probe
Hsa-miR-146b
Hsa-miR-200a
eFISH MET/CEN 7 Dual Color Probe
Hsa-miR-150
eFISH ETV6 Dual Color Break Apart Probe
Hsa-miR-1247 Probe
eFISH FOXO1 Dual Color Break Apart Probe
Hsa-miR-135b Probe
Hsa-miR-486 Probe
Hsa-miR140 Probe
Hsa-miR-125a Probe
Hsa-miR-628 Probe
Hsa-miR-409-3P Probe
Beta Actin Probe
eFISH CEN 9 Probe
Hsa-miR-424 Probe
Hsa-miR-203a
eFISH CEN 7 Probe
eFISH CEN 6 Probe
Hsa-miR223 Probe
Hsa-miR-let-7g Probe
Hsa-miR186 Probe
Hsa-miR-let-7b Probe
Hsa-miR-191 Probe
Hsa-miR-451 Probe
Hsa-miR-210 Probe
eFISH 13/CEN 18/21 Triple Color Probe
Hsa-miR-122 Probe
Hsa-miR1297 Probe
Hsa-miR-30b Probe
Hsa-miR-362 Probe
Hsa-miR-95 Probe
Hsa-miR-590 Probe
Hsa-miR-718 Probe
Hsa-miR-648 Probe
Hsa-miR-497 Probe
HSA-MIR-510 PROBE
ANTI-HER2/ERBB2
HSA-MIR-184 PROBE
HSA-MIR-765 PROBE
HSA-MIR-874 PROBE
ANTI-ESTROGEN RECEPTOR (ER) ALPHA
HSA-MIR-198 PROBE
HSA-MIR-374A PROBE
HSA-MIR-183-3P PROBE
HSA-MIR-296 PROBE
ANTI-PD-L1
ANTI-CD103
BRCA2 PROBE
HSA-MIR-495 PROBE
SCRAMBLE PROBE
ANTI-CDK9
HSA-MIR-34C PROBE
HSA-MIR-532 PROBE
HSA-MIR-425 PROBE
NTI-PAPILLOMAVIRUS TYPE 16 (HPV-16)
HSA-MIR-450B-3P PROBE
ARG2 PROBE
HSA-MIR-342-3P PROBE
HSA-MIR-517A-3P PROBE
CD68 PROBE
HSA-MIR-29A PROBE
ANTI-CYTOKERATIN 5 + CYTOKERATIN 14
HSA-MIR-339-3P PROBE
ANTI-HEPATITIS B VIRUS CORE ANTIGEN (HBCAG)
ANTI-PGP9.5
HSA-MIR-509-3P PROBE
HSA-MIR-136 PROBE
ANTI-PROSTATE SPECIFIC ACID PHOSPHATASE (PSAP)
HSA-MIR-508-3P PROBE
HSA-MIR-383 PROBE
ANTI-CD63
ANTI-CD35
HSA-MIR-338-3P PROBE
BCL2 PROBE
ANTI-EGFR
ANTI-CD41/INTEGRIN
HSA-MIR-130B PROBE
PCNA PROBE
ANTI-P504S (AMACR)
HSA-MIR-614 PROBE
HSA-MIR-330 PROBE
ANTI-GITR
HSA-MIR-4723 PROBE
HSA-MIR-197 PROBE
ANTI-C-KIT / CD117
ANTI-PMS2
HSA-MIR-650 PROBE
BRAF PROBE
ANTI-LAG3
ANTI-CD205
MPO PROBE
HSA-MIR-211 PROBE
HSA-MIR-154 PROBE
HSA-MIR-574A-3P PROBE
ANTI-IDO
U6 PROBE
MRC1 PROBE
HSA-MIR-16 PROBE
HSA-MIR-21 PROBE
HSA-MIR-142 PROBE
HSA-MIR-132 PROBE
HSA-MIR-486-3P PROBE
HSA-MIR-145 PROBE
HSA-MIR-1296 PROBE
HSA-MIR-940 PROBE
HSA-MIR-638 PROBE
HSA-MIR-216B PROBE
TNF PROBE
ANTI-CEACAM1
ANTI-CSF-1R
ANTI-BCR-ABL
ALK PROBE
ANTI-TOXOPLASMA GONDII
ANTI-P16 + KI67
ANTI-ADENOVIRUS
ANTI-C-ERBB-2 (HER-2/NEU)
HSA-MIR-193B PROBE
HSA-MIR-23A PROBE
COL1A1 PROBE
MYC PROBE
JAK2 PROBE
HSA-MIR-376C PROBE
HSA-MIR-374B PROBE
HSA-MIR-1258 PROBE
ANTI-HERPES SIMPLEX VIRUS TYPE II (HSV II)
ANTI-H.PYLORI
HSA-MIR-541 PROBE
HSA-MIR-129 PROBE
SERPINE1 PROBE
HSA-MIR-372 PROBE
ANTI-GLYCOPHORIN A + B
ANTI-CD21
ANTI-PROGESTERONE RECEPTOR (PR)
HSA-MIR-642 PROBE
HSA-MIR-183 PROBE
ANTI-PROSTATE SPECIFIC ANTIGEN (PSA)
HSA-MIR-29B PROBE
HSA-MIR-944 PROBE
ANTI-CYTOKERATIN 4
HPV 14 PROBE
TTF1 PROBE
HSA-MIR-502 PROBE
ANTI-EPSTEIN-BARR VIRUS (EBV) EARLY ANTIGEN
ANTI-P16 (INK4A)
HSA-MIR-337 PROBE
HSA-MIR-379 PROBE
ANTI-CD40
ANTI-CD27
HSA-MIR-520 PROBE
HSA-MIR-300 PROBE
ANTI-SLAMF7
ANTI-ANDROGEN RECEPTOR
HSA-MIR-511 PROBE
ARG1 PROBE
ANTI-GLYPICAN-3 (GPC3)
ANTI-CD95
HSA-MIR-573 PROBE
HSA-MIR-137 PROBE
HSA-MIR-24-2 PROBE
ANTI-CD48
ABL1 PROBE
ANTI-CD73
Hsa miR 17 3p
Hsa miR 26b
Hsa miR 365a 3p
Hsa miR 638
Hsa miR 944
In situ Sequencing Assay Kit
Anti Her2
Complementary Probe to Anti PDL1 Cy5
Hsa miR 135a
Hsa miR 147b
Hsa miR 200c
Hsa miR 216b
Hsa miR 31
Hsa miR 544
Super Sensitive Mouse on Mouse M O M 1 step Poly HRP kit
Hsa miR 181a
Hsa miR 27a
Hsa miR 372
Hsa miR 423 3p
Hsa miR 641
Hsa miR 95
miRFISH Assay Kit
Oligo barcoded Anti HLA DR
Anti Cytomegalovirus
Complementary Probe to Anti ER Cy3
Hsa miR 182
Hsa miR 197
Hsa miR 374b
Hsa miR 429
Hsa miR 98
Anti Cytokeratin pan
Complementary Probe to Anti p53 TET
Hsa miR 133a
Hsa miR 200a
Hsa miR 215
Hsa miR 483
Hsa miR 532
Complementary Probe to Anti CD8 Cy3
Genotyping & Phenotyping Assay Kit
Hsa miR 125b
Hsa miR 193b
Hsa miR 205
Hsa miR 28 3p
Hsa miR 422a
Hsa miR 497
Complementary Probe to Anti CD206 TYE705
Hsa miR 154
Hsa miR 185
Hsa miR 339 3p
Hsa miR 379
Hsa miR 765
Oligo barcoded Anti CD8
Complementary Probe to Anti HLA DR FAM
Hsa miR 130b
Hsa miR 19a
Hsa miR 451
Hsa miR 517 3p
Hsa miR LET 7a
Oligo barcoded Anti PR
Complementary Probe to Anti CD68 TYE705
eFISH Assay Kit
Hsa miR 125a
Hsa miR 192
Hsa miR 204
Hsa miR 412
Hsa miR 495
Oligo barcoded Anti FoxP3
Hsa miR 1181
Hsa miR 145
Hsa miR 15b
Hsa miR 24 3p
Hsa miR 30b
Hsa miR 34c
Hsa miR 628
Hsa miR LET 7e
Complementary Probe to Anti CD45 HEX
Hsa miR 1247
Hsa miR 18a
Hsa miR 409 3p
Hsa miR 486 3p
Hsa miR 9
Oligo barcoded Anti EGFR
Hsa miR 146a
Hsa miR 16
Hsa miR 25
Hsa miR 30c
Hsa miR 361
Hsa miR 629
Hsa miR 92a
Hsa miR LET 7g
Anti COX2
Hsa miR 181b
Hsa miR 195
Hsa miR 27b
Hsa miR 373
Hsa miR 424
Hsa miR 9500
Oligo barcoded Anti CD206
Oligo barcoded Anti Ki 67
Complementary Probe to Anti CXCR2 Cy3
Hsa miR 100
Hsa miR 127 3p
Hsa miR 140
Hsa miR 20a
Hsa miR 296
Hsa miR 505
Anti dsDNA
Complementary Probe to Anti FoxP3 Cy5
Hsa miR 1296
Hsa miR 183
Hsa miR 198
Hsa miR 449a
Hsa miR 99a
Oligo barcoded Anti PD1
Anti p40
Complementary Probe to Anti Her2 FAM
Hsa miR 1297
Hsa miR 199a
Hsa miR 450b 3p
Hsa miR 99b
Oligo barcoded Anti PDL1
Hsa miR 106a
Hsa miR 142 3p
Hsa miR 211
Hsa miR 23a
Hsa miR 29b
Hsa miR 510
Hsa miR 622
Hsa miR LET 7b
Complementary Probe to Anti Ki67 Cy3
Hsa miR 132
Hsa miR 19b 3p
Hsa miR 214
Hsa miR 4723
Hsa miR 520
U6
Complementary Probe to Anti PD1 TYE705
Hsa miR 133b
Hsa miR 200b
Hsa miR 216a
Hsa miR 30e
Hsa miR 486
Hsa miR 541 probe
Hsa miR 136
Hsa miR 148b
Hsa miR 218
Hsa miR 329
Hsa miR 573
Hsa miR 642
Complementary Probe to Anti CD4 HEX
Hsa miR 124
Hsa miR 187
Hsa miR 383
Hsa miR 874
Oligo barcoded Anti CXCR2
Complementary Probe to Anti Chromogranin A Cy5
Hsa miR 1
Hsa miR 126
Hsa miR 138
Hsa miR 194
Hsa miR 206
Hsa miR 28 5p
Hsa miR 502
Anti Progesterone Receptor
Complementary Probe to Anti EGFR HEX
Hsa miR 181c
Hsa miR 196a
Hsa miR 374a
Hsa miR 425
Hsa miR 96
Oligo barcoded Anti CD3
Oligo barcoded Anti p53
Hsa miR 152
Hsa miR 183 3p
Hsa miR 223
Hsa miR 337
Hsa miR 376
Hsa miR 708
Oligo barcoded Anti CD56
Hsa miR 137
Hsa miR 149
Hsa miR 22
Hsa miR 330
Hsa miR 574 3p
Hsa miR 648
Anti STAT5 alpha
Hsa miR 153
Hsa miR 184
Hsa miR 338
Hsa miR 378a
Hsa miR 718
Oligo barcoded Anti CD68
Complementary Probe to Anti PR FAM
Hsa miR 135b
Hsa miR 148a
Hsa miR 217
Hsa miR 328
Hsa miR 545 5p
Hsa miR 150
Hsa miR 221 3p
Hsa miR 331 3p
Hsa miR 590
Hsa miR 650
Oligo barcoded Anti CD4
Hsa miR 101
Hsa miR 1285
Hsa miR 141
Hsa miR 21
Hsa miR 297
Hsa miR 508 3p
Hsa miR 614
Complementary Probe to Anti CD56 Cy5
Hsa miR 1258
Hsa miR 191
Hsa miR 203a
Hsa miR 410
Hsa miR 494
Anti ER
Hsa miR 10b
Hsa miR 144
Hsa miR 15a
Hsa miR 21 3p
Hsa miR 24 2 5p
Hsa miR 300
Hsa miR 34a
Hsa miR 627
Hsa miR LET 7d
Hsa miR 151a 3p
Hsa miR 222
Hsa miR 335
Hsa miR 375
Hsa miR 610
Hsa miR 663a
Anti CD45
Hsa miR 146b
Hsa miR 17
Hsa miR 26a
Hsa miR 362
Hsa miR 630
Hsa miR 940
ImmunoPlex Assay Kit
Complementary Probe to Anti CD3 FAM
Hsa miR 122
Hsa miR 155
Hsa miR 186
Hsa miR 381
Hsa miR 802
Oligo barcoded Anti Chromogranin A
Hsa miR 101 3p
Hsa miR 129
Hsa miR 142
Hsa miR 210
Hsa miR 224
Hsa miR 29a
Hsa miR 509 3p
Hsa miR 615
Hsa miR 107
Hsa miR 143
Hsa miR 212
Hsa miR 23b
HSA miR 29c
Hsa miR 342 3p
Hsa miR 511
Hsa miR 625
Hsa miR LET 7c
Establishment Types
Manufacture Medical Device