Company ยท US
Biogenex Laboratories
FDA 510(k) clearances and medical device recalls filed under this name, 1981 to 2002. Name variants (Inc, Corp, punctuation) are merged.
12510(k) clearances (0 in 12 months)
11recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JHI | Visual, Pregnancy Hcg, Prescription Use | 5 |
| MVC | System, Test, Her-2/Neu, Ihc | 5 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 2 |
| JFH | Acid Phosphatase (Prostatic), Tartrate Inhibited | 2 |
| KEY | Stainer, Tissue, Automated | 2 |
| MVU | Reagents, Specific, Analyte | 2 |
| NJT | Immunohistochemistry Reagents And Kits | 2 |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 1 |
| MXZ | Immunohistochemistry Assay, Antibody, Progesterone Receptor | 1 |
| MYA | Immunohistochemistry Antibody Assay, Estrogen Receptor | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 8, 2002 | K012960 | BIOGENEX MONOCLONAL ANTI-PROGESTERONE RECEPTOR Biogenex Laboratories | MXZ |
| Feb 28, 2002 | K013148 | BIOGENEX MONOCLONAL ANTI-ESTROGEN RECEPTOR(CLONE ER88) Biogenex Laboratories | MYA |
| Jan 6, 1993 | K925189 | PREGNAGEN 1-STEP PREGNANCY TEST Biogenex Laboratories | LCX |
| Jul 17, 1990 | K902208 | MODIFIED OVUGEN Biogenex Laboratories | CEP |
| Jan 13, 1989 | K884880 | PREGNAGEN(TM) Biogenex Laboratories | JHI |
| Sep 9, 1988 | K882002 | PREGNAGEN(TM) Biogenex Laboratories | JHI |
| Nov 23, 1987 | K873534 | OVUGEN SURETEST Biogenex Laboratories | CEP |
| Jun 2, 1983 | K831221 | RIAGEN B-HCG RIA KIT Biogenex Laboratories | JHI |
| Jul 13, 1982 | K821657 | RIAGEN B-HCG RIA Biogenex Laboratories | JHI |
| May 21, 1982 | K821234 | RIAGEN B-HCG RIA Biogenex Laboratories | JHI |
| Apr 14, 1982 | K820724 | FLUOROGEN PAP FIA Biogenex Laboratories | JFH |
| Dec 17, 1981 | K813261 | RIAGEN PAP RIA Biogenex Laboratories | JFH |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 24, 2014 | Biogenex Laboratories, Inc. InSite HER-2 Detection Kit, an immunohistochemistry assay for in vitro diagnostic use. Terminated |
MVC | None listed |
| Mar 8, 2010 | Biogenex Laboratories 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 Sa Terminated |
KEY | None listed |
| Aug 22, 2008 | Biogenex Laboratories Xmatrx FISH (fluorescent in situ hybridization) Automated Staining System, Catalog number AS4010B Terminated |
KEY | None listed |
| Dec 8, 2006 | Biogenex Laboratories 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. Terminated |
NJT | None listed |
| Sep 23, 2006 | Biogenex Laboratories Anti-CD45 Cocktail antibody in 6 ml vials; Cat. No. AM371-5M , manufactured and distributed by BioGenex, San Ramon, CA Terminated |
NJT | None listed |
| Aug 29, 2006 | Biogenex Laboratories 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 Terminated |
MVU | None listed |
| Aug 29, 2006 | Biogenex Laboratories 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 Terminated |
MVU | None listed |
| Mar 15, 2006 | Biogenex Laboratories 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;
Lo Terminated |
MVC | None listed |
| Mar 15, 2006 | Biogenex Laboratories 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 Num Terminated |
MVC | None listed |
| Mar 15, 2006 | Biogenex Laboratories 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: RD Terminated |
MVC | None listed |
| Mar 15, 2006 | Biogenex Laboratories 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: RD134 Terminated |
MVC | None listed |