Biokit USA, Inc.
Mchenry, IL, US
Biokit USA, Inc. appears in FDA device records in Mchenry, IL. FDA records list 16 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 2 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 16 510(k) clearances for Biokit USA, Inc. between 1984 and 1993. The busiest year on record is 1989, with 5. The most recent is 1993, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1984 | 2 |
| 1986 | 1 |
| 1987 | 1 |
| 1989 | 5 |
| 1990 | 1 |
| 1991 | 5 |
| 1993 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K913467 | TOXOGEN | LLA | Substantially Equivalent | |
| K910541 | BIOKIT RPR | GMQ | Substantially Equivalent | |
| K904310 | RHEUMAGEN RF T-CONTROL | DHR | Substantially Equivalent | |
| K910539 | RHEUMAJET RF | DHR | Substantially Equivalent | |
| K910686 | RHEUMAJET CRP | DCN | Substantially Equivalent | |
| K904311 | RHEUMAGEN ASO T-CONTROL | GTQ | Substantially Equivalent | |
| K904312 | RHEUMAGEN CRP T-CONTROL | DCK | Substantially Equivalent | |
| K896433 | MODIFIED RUBAGEN | LQN | Substantially Equivalent | |
| K896272 | QUANTEX CRP PLUS (LATEX, BUFFER, STANDARD, CONTROL | DCN | Substantially Equivalent | |
| K896271 | QUANTEX RF PLUS (LATEX, BUFFER STANDARD, CONTROL) | DHR | Substantially Equivalent | |
| K894486 | QUANTEX ASO PLUS (LATEX,BUFFER STANDARD,CONTROL) | GTQ | Substantially Equivalent | |
| K893755 | RUBAGEN | LQN | Substantially Equivalent | |
| K874678 | I.M.N. LATEX | KTN | Substantially Equivalent | |
| K854991 | REUMAGEN ASL | GTQ | Substantially Equivalent | |
| K843741 | RPR TEST REDITEST | GMP | Substantially Equivalent | |
| K842256 | AS LATEX PLUS | GTQ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- GMQAntigens, Nontreponemal, All
- GMPAntisera, Control For Nontreponemal Tests
- GTQAntistreptolysin - Titer/Streptolysin O Reagent
- DCKC-Reactive Protein, Antigen, Antiserum, And Control
- LLADirect Agglutination Test, Toxoplasma Gondii
- LQNLatex Agglutination Assay, Rubella
- DCNSystem, Test, C-Reactive Protein
- KTNSystem, Test, Infectious Mononucleosis
- DHRSystem, Test, Rheumatoid Factor
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1971-2010 | Sure-Vue HSV-2 Rapid Test, Catalogue No: 23-046395. 20 test Kit In Vitro Diagnostic test for Herpes Simplex Virus 2 | Negative serum was giving a positive result Herpes Simplex Type 2 (HSV-2). It is possible that misdiagnosis (i.e., positive) could be made. | Terminated | ||
| Z-1970-2010 | Biokit HSV-2 Rapid test Catalogue Number: 3000-28001. 20 test Kit. In Vitro Diagnostic test for Herpes Simplex Virus 2. | Negative serum was giving a positive result Herpes Simplex Type 2 (HSV-2). It is possible that misdiagnosis (i.e., positive) could be made. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain