Immunoassay Control Level 3
Catalogue number 94103, listed by Cliniqa Corporation, United States, under Multi-Analyte Controls, All Kinds (Assayed). 1 manufacturer in China is registered for this product code.
1manufacturer
1catalogue number
22510(k) clearances naming this product code
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Getein Biotech, Inc. | Nanjing | Jiangsu | Manufacturer | 19 |
Record
| Listed by | Cliniqa Corporation, United States |
|---|---|
| FDA product code | JJY |
| Device type | Multi-Analyte Controls, All Kinds (Assayed) |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1660 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| 510(k) | K083554 |
| Record published | 2018-08-22 |
| Record revised | 2020-12-21 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 94103 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Liquichek | Bio-Rad Laboratories Inc. | 154 |
| Validate | LGC Clinical Diagnostics, Inc. | 120 |
| InteliQ | Bio-Rad Laboratories Inc. | 50 |
| Lyphochek | Bio-Rad Laboratories Inc. | 39 |
| Stat Profile | Nova Biomedical Corporation | 38 |
| i-STAT | Abbott Point OF Care Inc. | 24 |
| Multichem AE | Techno-Path Manufacturing Ltd. | 20 |
| Serum Control | Chromsystems Instruments & Chemicals Gmbh | 18 |
| BioPlex 2200 | Bio-Rad Laboratories Inc. | 16 |
| Nova | Nova Biomedical Corporation | 14 |
| Plasma Control | Chromsystems Instruments & Chemicals Gmbh | 14 |
| Multichem IA Speciality | Techno-Path Manufacturing Ltd. | 12 |
Showing 12 of 559. All products under Multi-Analyte Controls, All Kinds (Assayed)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K083554 | 2009-04-21 |
| K082107 | 2008-09-17 |
| K080973 | 2008-06-02 |
| K070741 | 2007-05-04 |
| K062916 | 2006-10-23 |
| K061182 | 2006-05-25 |
| K040535 | 2004-03-29 |
| K040091 | 2004-02-23 |
| K032074 | 2003-10-21 |
| K033162 | 2003-10-10 |
| K031921 | 2003-08-25 |
| K031577 | 2003-08-06 |
| K031575 | 2003-07-23 |
| K030705 | 2003-03-26 |
| K030566 | 2003-03-13 |
| K030150 | 2003-01-28 |
| K023661 | 2002-12-06 |
| K023250 | 2002-10-17 |
| K022885 | 2002-10-02 |
| K022936 | 2002-10-02 |
| K022867 | 2002-10-02 |
| K013332 | 2001-11-20 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.