Company ยท ES
Biokit, S.A.
FDA 510(k) clearances and medical device recalls filed under this name, 1984 to 2025. Name variants (Inc, Corp, punctuation) are merged.
39510(k) clearances (0 in 12 months)
3recalls (0 in 12 months)
3recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GTQ | Antistreptolysin - Titer/Streptolysin O Reagent | 4 |
| DHR | System, Test, Rheumatoid Factor | 3 |
| LGC | Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific | 3 |
| CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | 2 |
| DCN | System, Test, C-Reactive Protein | 2 |
| DGC | Ige, Antigen, Antiserum, Control | 2 |
| JIT | Calibrator, Secondary | 2 |
| JZG | System, Test, Beta-2-Microglobulin Immunological | 2 |
| LEH | Radioimmunoassay, Vancomycin | 2 |
| LQN | Latex Agglutination Assay, Rubella | 2 |
| MXJ | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 | 2 |
| MYF | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 | 2 |
| CEW | Radioimmunoassay, Parathyroid Hormone | 1 |
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | 1 |
| DEM | Alpha-1-Antitrypsin, Antigen, Antiserum, Control | 1 |
| DFC | Lipoprotein, Low-Density, Antigen, Antiserum, Control | 1 |
| GMP | Antisera, Control For Nontreponemal Tests | 1 |
| GMQ | Antigens, Nontreponemal, All | 1 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 |
| KTN | System, Test, Infectious Mononucleosis | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 12, 2025 | K243575 | ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls Biokit, S.A., ES | MYF |
| Aug 7, 2024 | K233606 | ADVIA Centaur EBV-VCA IgM Biokit, S.A., ES | LSE |
| Aug 7, 2024 | K233605 | ADVIA Centaur EBV-EBNA IgG Biokit, S.A., ES | LLM |
| Sep 20, 2023 | K213987 | ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls Biokit, S.A., ES | MXJ |
| Feb 21, 2023 | K214068 | Quantia IgE Biokit, S.A., ES | DGC |
| Aug 23, 2018 | K181334 | ADVIA Centaur Herpes-2 IgG Biokit, S.A., ES | MYF |
| Aug 23, 2018 | K181333 | ADVIA Centaur Herpes-1 IgG Biokit, S.A., ES | MXJ |
| Feb 11, 2016 | K152185 | ARCHITECT SHBG Biokit, S.A., ES | CDZ |
| Dec 19, 2013 | K132400 | LP(A) CALIBRATORS, AND LP(A) CONTROLS Biokit, S.A., ES | JIT |
| Aug 29, 2013 | K123947 | ARCHITECT IVANCOMYCIN Biokit, S.A., ES | LEH |
| Nov 23, 2011 | K110619 | ARCHITECT 25-OH VITAMIN D 100T, VITAMIN D 500T, VITAMIN D CALIBRATORS, VITAMIN D CONTROLS Biokit, S.A., ES | MRG |
| Dec 22, 2008 | K082953 | ARCHITECT IDIGOXIN AND ARCHITECT IDIGOXIN CALIBRATORS, MODELS 1P32-25 AND IP32-01 Biokit, S.A., ES | KXT |
| Sep 3, 2008 | K082141 | ARCHITECT C-PEPTIDE CALIBRATORS, AND ARCHITECT C-PEPTIDE CONTROLS, MODELS 3L53-01, 3L53-10 Biokit, S.A., ES | JIT |
| Mar 19, 2008 | K072036 | ARCHITECT IVANCOMYCIN REAGENTS AND ARCHITECT IVANCOMYCIN CALIBRATORS, MODELS: 1P30-25 AND 1P30-01 Biokit, S.A., ES | LEH |
| Dec 19, 2007 | K072078 | QUANTIA BETA-2 MICROGLOBULIN, MODEL: 302822307 Biokit, S.A., ES | JZG |
| Jun 19, 2007 | K063232 | ARCHITECT INTACT PTH REAGENTS, CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM, HIGH), MODELS 8K25-20, 8K25-25, 8K25-01 Biokit, S.A., ES | CEW |
| Jun 8, 2007 | K070810 | ARCHITECT I THEOPHYLLINE REAGENTS AND CALIBRATORS (A-F) Biokit, S.A., ES | LGS |
| Jan 23, 2007 | K060818 | ARCHITECT SHBG REAGENT KIT, ARCHITECT SHBG CALIBRATOR KIT, AND ARCHITECT SHBG CONTROL KIT WITH MODELS, 8K26-25, 8K26-01 Biokit, S.A., ES | CDZ |
| Jan 26, 2006 | K060027 | ARCHITECT DHEA-S CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM AND HIGH) Biokit, S.A., ES | JJX |
| Aug 16, 2005 | K050613 | QUANTIA BETA-2 MICROGLOBULIN Biokit, S.A., ES | JZG |
| Aug 16, 2005 | K050493 | QUANTIA IGE Biokit, S.A., ES | DGC |
| May 13, 2005 | K050596 | QUANTIA A1-AT Biokit, S.A., ES | DEM |
| Apr 26, 2005 | K050487 | QUANTIA LA(A) Biokit, S.A., ES | DFC |
| Jan 11, 1993 | K913467 | TOXOGEN Biokit USA, Inc., ES | LLA |
| Oct 18, 1991 | K910541 | BIOKIT RPR Biokit USA, Inc., ES | GMQ |
| May 31, 1991 | K904310 | RHEUMAGEN RF T-CONTROL Biokit USA, Inc., ES | DHR |
| Apr 5, 1991 | K910539 | RHEUMAJET RF Biokit USA, Inc., ES | DHR |
| Mar 19, 1991 | K910686 | RHEUMAJET CRP Biokit USA, Inc., ES | DCN |
| Jan 25, 1991 | K904311 | RHEUMAGEN ASO T-CONTROL Biokit USA, Inc., ES | GTQ |
| Oct 1, 1990 | K904312 | RHEUMAGEN CRP T-CONTROL Biokit USA, Inc., ES | DCK |
| Nov 29, 1989 | K896433 | MODIFIED RUBAGEN Biokit USA, Inc., ES | LQN |
| Nov 8, 1989 | K896272 | QUANTEX CRP PLUS (LATEX, BUFFER, STANDARD, CONTROL Biokit USA, Inc., ES | DCN |
| Nov 8, 1989 | K896271 | QUANTEX RF PLUS (LATEX, BUFFER STANDARD, CONTROL) Biokit USA, Inc., ES | DHR |
| Oct 24, 1989 | K894486 | QUANTEX ASO PLUS (LATEX,BUFFER STANDARD,CONTROL) Biokit USA, Inc., ES | GTQ |
| Aug 21, 1989 | K893755 | RUBAGEN Biokit USA, Inc., ES | LQN |
| Dec 14, 1987 | K874678 | I.M.N. LATEX Biokit USA, Inc. | KTN |
| Apr 18, 1986 | K854991 | REUMAGEN ASL Biokit USA, Inc., ES | GTQ |
| Oct 25, 1984 | K843741 | RPR TEST REDITEST Biokit USA, Inc. | GMP |
| Jun 19, 1984 | K842256 | AS LATEX PLUS Biokit USA, Inc. | GTQ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 26, 2023 | Biokit, S.A. biokitHSV-2 Rapid Test, REF: 300028001 Open, Classified |
LGC | K983886 |
| Jul 8, 2010 | Biokit U.S.A. Inc. Sure-Vue HSV-2 Rapid Test, Catalogue No: 23-046395.
20 test Kit
In Vitro Diagnostic test for Herpes Simplex Virus 2 Terminated |
LGC | K983886 |
| Jul 8, 2010 | Biokit U.S.A. Inc. Biokit HSV-2 Rapid test Catalogue Number: 3000-28001.
20 test Kit.
In Vitro Diagnostic test for Herpes Simplex Virus 2. Terminated |
LGC | K983886 |