Biogenex Laboratories, Inc.
Fremont, CA, US
BIOGENEX LABORATORIES INC. appears in FDA device records in Fremont, CA. FDA records list 12 510(k) clearances between and , one PMA record and one registered establishment. As of , FDA records show 11 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 12 510(k) clearances for Biogenex Laboratories, Inc. between 1981 and 2002. The busiest year on record is 1982, with 3. The most recent is 2002, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1981 | 1 |
| 1982 | 3 |
| 1983 | 1 |
| 1987 | 1 |
| 1988 | 1 |
| 1989 | 1 |
| 1990 | 1 |
| 1993 | 1 |
| 2002 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K012960 | BIOGENEX MONOCLONAL ANTI-PROGESTERONE RECEPTOR | MXZ | Substantially Equivalent | |
| K013148 | BIOGENEX MONOCLONAL ANTI-ESTROGEN RECEPTOR(CLONE ER88) | MYA | Substantially Equivalent | |
| K925189 | PREGNAGEN 1-STEP PREGNANCY TEST | LCX | Substantially Equivalent | |
| K902208 | MODIFIED OVUGEN | CEP | Substantially Equivalent | |
| K884880 | PREGNAGEN(TM) | JHI | Substantially Equivalent | |
| K882002 | PREGNAGEN(TM) | JHI | Substantially Equivalent | |
| K873534 | OVUGEN SURETEST | CEP | Substantially Equivalent | |
| K831221 | RIAGEN B-HCG RIA KIT | JHI | Substantially Equivalent | |
| K821657 | RIAGEN B-HCG RIA | JHI | Substantially Equivalent | |
| K821234 | RIAGEN B-HCG RIA | JHI | Substantially Equivalent | |
| K820724 | FLUOROGEN PAP FIA | JFH | Substantially Equivalent | |
| K813261 | RIAGEN PAP RIA | JFH | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3008776165 | 2936532 | BIOGENEX LABORATORIES INC. | 48810 Kato Road,Suite 100E&200E, Fremont, CA 94538 US | 2026 | and 26 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- JFHAcid Phosphatase (Prostatic), Tartrate Inhibited
- IDAAlcian Blue
- ICQAzure A
- ICLCarbol Fuchsin
- ICHCongo Red
- LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
- KEOFormulations, Paraffin, All
- PPMGeneral Purpose Reagent
- HYFGiemsa Stain
- HYJHematoxylin
- HYLHematoxylin Mayer'S
- MYAImmunohistochemistry Antibody Assay, Estrogen Receptor
- MXZImmunohistochemistry Assay, Antibody, Progesterone Receptor
- NJTImmunohistochemistry Reagents And Kits
- GGHIron Stains
- LCXKit, Test, Pregnancy, Hcg, Over The Counter
- HYZMethenamine Silver
- HZAMethyl Green
- HZCMucicarmine
- HZFNuclear Fast Red
- HZGOil Red O
- JCCPh Buffer
- IEOProcessor, Tissue, Automated
- CEPRadioimmunoassay, Luteinizing Hormone
- HZTReagent, Schiff
- MVUReagents, Specific, Analyte
- HZSSafranin
- HZXSilver Nitrate
- KPASlide Stainer, Automated
- KEWSlides, Microscope
- KKPSolution, Silver Carbonate
- HZJStain, Papanicolau
- HYWStain, Trichrome, Mallory'S
- KEYStainer, Tissue, Automated
- LEEStains, Dye Solution
- JTSStains, Microbiologic
- HZZSudan Black B
- MVCSystem, Test, Her-2/Neu, Ihc
- IABToluidine Blue
- IBGTrypsin
- JHIVisual, Pregnancy Hcg, Prescription Use
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2113-2014 | InSite HER-2 Detection Kit, an immunohistochemistry assay for in vitro diagnostic use. | Product was distributed without 510(k) approval. | Class II | Terminated | |
| Z-1016-2010 | Xmatrx FISH (fluorescent in situ hybridization) Automated Staining System; Model Number/Catalog Number: AS4010B; The product is manufactured by: BioGenex Laboratories, Inc. 4600 Norris Canyon Road San Ramon, CA 94583 and Distributed by: Abbott Molecular, 1300 E. Touhy Ave - 2E, Des Plaines, IL 60018 Xmatrx Automated Staining System is intended for in vitro diagnostic use. It is suitable for fluorescent hybridization (FISH) applications. | Under certain conditions, product system failure has the potential to cause operator injury due to splash of Hemo-De solution. | Terminated | ||
| Z-1471-2008 | Xmatrx FISH (fluorescent in situ hybridization) Automated Staining System, Catalog number AS4010B | Bulk reagent dispensing mechanism may break resulting in reagent spill and possible exposure to chemicals. | Terminated | ||
| Z-0217-2007 | Super Sensitive Link-Label IHC Detection System/Mega Volume, RTU Multi-Link-HRP, REF/Cat. No. QP300-XAK, Kit containing reagent vials, Bio-Genex, San Ramon, CA. | Mislabeling: The product's "contents section " labeling (outer box) is mislabeled incorrectly printed as '1 x 100 mL Alk Phos Label' which should read '1 x 100 mL HRP Label'. A second, smaller label, incorrectly reads "RTU MultiLink HPR/AEC" which should be labeled as "RTU MultiLink HPR". The reagent vials in the box are correctly labeled. | Terminated | ||
| Z-1519-06 | Anti-CD45 Cocktail antibody in 6 ml vials; Cat. No. AM371-5M , manufactured and distributed by BioGenex, San Ramon, CA | Mislabeling: Anti-CD45 cocktail antibody mislabeled as Ki-67. | Terminated | ||
| Z-1439-06 | BioGenex brand Hepatitis B Virus Surface Antigen Antibody, Cat. No. AM364-5M and MU364-UC, Product is distributed by BioGenex Laboratories, 4600 Norris Canyon Rd., San Ramon, CA 94583 | Misbranding-The product labeling (label and insert) is misbranded in that the product does not comply with the labeling requirements for an Analyte Specific | Terminated | ||
| Z-1438-06 | BioGenex brand Hepatitis B Virus Core Antigen Antibody, Cat. No. AR082-5R and PU082-UP, Product is distributed by BioGenex Laboratories, 4600 Norris Canyon Rd., San Ramon, CA 94583 | Misbranding-The product labeling (label and insert) is misbranded in that the product does not comply with the labeling requirements for an Analyte Specific Reagent (ASR). | Terminated | ||
| Z-0609-06 | Test kit used in the assessment of breast cancer patients for whom Herceptin therapy is being considered. BioGenex brand InSite HER-2/neu Monoclonal Antibody, Automated; Model number: AM134-10MP; Lot Numbers: AM134P1005 | Products produce granular staining in immunostained tissue sections, which may lead to misdiagnosis due to false positive result. | Terminated | ||
| Z-0608-06 | Test kit used in the assessment of breast cancer patients for whom Herceptin therapy is being considered. BioGenex brand InSite HER-2/neu Monoclonal Antibody, Manual; Model number: AM134-5MP; Lot Numbers: AM134P1005 | Products produce granular staining in immunostained tissue sections, which may lead to misdiagnosis due to false positive result. | Terminated | ||
| Z-0607-06 | Test kit used in the assessment of breast cancer patients for whom Herceptin therapy is being considered. BioGenex brand InSite HER-2/neu IHC Kit, Automated; Model Numbers: RD134-YAX; Lot Numbers: RD1340205, RD1340205X, RD1341105, RD1340206 | Products produce granular staining in immunostained tissue sections, which may lead to misdiagnosis due to false positive result. | Terminated | ||
| Z-0606-06 | Test kit used in the assessment of breast cancer patients for whom Herceptin therapy is being considered. BioGenex brand InSite HER-2/neu IHC Kit, Manual; Model Numbers: RD134-60K; Lot Numbers: RD1340205, RD1340205X, RD1340205Y | Products produce granular staining in immunostained tissue sections, which may lead to misdiagnosis due to false positive result. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain