Ionify ControlSet Steroids and Vitamin D
Catalogue number 09646965160, listed by Roche Diagnostics Gmbh, Germany, 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
4recalls on this 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 | Roche Diagnostics Gmbh, Germany |
|---|---|
| FDA product code | JJY |
| Device type | Multi-Analyte Controls, All Kinds (Assayed) |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1660 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2025-06-25 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 09646965160 | 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 |
|---|---|
| K111506 | 2011-07-08 |
| K102016 | 2010-09-01 |
| K102157 | 2010-08-27 |
| K092320 | 2009-11-03 |
| K090541 | 2009-07-02 |
| K070200 | 2007-03-19 |
| K062379 | 2007-01-31 |
| K060429 | 2006-03-15 |
| K051543 | 2005-10-17 |
| K051687 | 2005-07-25 |
| K051185 | 2005-07-06 |
| K051517 | 2005-07-05 |
| K050387 | 2005-04-25 |
| K042389 | 2004-09-14 |
| K041812 | 2004-07-27 |
| K041227 | 2004-05-27 |
| K040280 | 2004-03-11 |
| K033937 | 2004-01-07 |
| K032089 | 2003-07-30 |
| K000270 | 2000-03-07 |
| K993360 | 1999-11-24 |
| K992900 | 1999-11-24 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2017-04-10 | Class II | Process control | e-barcode and value sheet for PreciControl Varia contains a typographical error for the target values for the Elecsys PTH (parathyroid hormone) and Elecsys PTH STAT immunoassays | 1603 | 2017-08-04 |
| 2007-12-04 | Not classified | Software design | Incorrect results: CRP assays may be calculated using incorrect calibration parameters which could result in falsely high or falsely low patient results being reported. | 1 | 2008-08-04 |
| 2007-11-14 | Not classified | Process design | High Quality Control Recovery: Undetected high quality control recovery in bicarbonate assay. | 811 | 2009-09-22 |
| 2007-11-14 | Not classified | Process design | High Quality Control Recovery: Undetected high quality control recovery in bicarbonate assay. | 1,296 | 2009-09-22 |
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.