Vitros
VITROS Immunodiagnostic Products Total ß-hCG II Range Verifiers
12manufacturers in China registered for this device type
55catalogue numbers in this listing
13510(k) clearances naming this product code
3recalls on this code
Who Else Makes It
Concentrated in Zhejiang (3), Guangdong (3), Jilin (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Acon Biotech (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 29 |
| Flextronics Industrial (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 5 |
| Yasee Biomedical Inc | Qingdao | Shandong | Contract manufacturer | 5 |
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Vivachek Biotech (Hangzhou) Co., Ltd. | Hangzhou, Zhuji | Zhejiang | Contract manufacturer | 21 |
| Guangdong Transtek Medical Electronics Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 11 |
| Tianjin Empecs Medical Device Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 8 |
| BD Rapid Diagnostics (Suzhou) Co., Ltd. | China (Jiangsu) Pilot Free Trade Zone Suzhou Area | Manufacturer | 6 | |
| Sejoy Biomedical Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 5 |
| Beijing Genesee Biotech, Inc. | Beijing | Beijing | Manufacturer | 4 |
| Human Metabolomics Institute, Inc. | Shenzhen | Guangdong | Manufacturer | 4 |
| Changsha Sinocare Inc. | Changsha | Hunan | Manufacturer | 2 |
Record
| Listed by | Ortho-Clinical Diagnostics, Inc., United States |
|---|---|
| FDA product code | JJX |
| Device type | Single (Specified) Analyte Controls (Assayed And Unassayed) |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1660 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-04-18 |
| Record revised | 2023-06-21 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature -18 to -18 °C |
| Packaging | Case of 30, case of 60 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6801770 | In distribution | |
| 6800880 | In distribution | |
| 6800366 | In distribution | |
| 6800661 | In distribution | |
| 6800874 | In distribution | |
| 6800380 | In distribution | |
| 6800336 | In distribution | |
| 6800373 | In distribution | |
| 6177335 | In distribution | |
| 6802242 | In distribution | |
| 6800872 | In distribution | |
| 6800372 | In distribution | |
| 6800378 | In distribution | |
| 6800370 | In distribution | |
| 6802894 | In distribution | |
| 6808890 | In distribution | |
| 6801430 | In distribution | |
| 6800877 | In distribution | |
| 6802222 | In distribution | |
| 6800878 | In distribution | |
| 6802895 | In distribution | |
| 6800873 | In distribution | |
| 6801463 | In distribution | |
| 6842957 | In distribution | |
| 6808896 | In distribution | |
| 6801769 | In distribution | |
| 6800371 | In distribution | |
| 6802312 | In distribution | |
| 6900040 | In distribution | |
| 6801427 | In distribution | |
| 1420025 | In distribution | |
| 6801746 | In distribution | |
| 6801747 | In distribution | |
| 6802158 | In distribution | |
| 6800377 | In distribution | |
| 6923436 | In distribution | |
| 6801044 | In distribution | |
| 6802311 | In distribution | |
| 6844507 | In distribution | |
| 6800879 | In distribution | |
| 6800660 | In distribution | |
| 6800369 | In distribution | |
| 6802093 | In distribution | |
| 6800876 | In distribution | |
| 6800374 | In distribution | |
| 6800375 | In distribution | |
| 6801421 | In distribution | |
| 6802303 | In distribution | |
| 6802313 | In distribution | |
| 6800367 | In distribution | |
| 6192257 | In distribution | |
| 6800368 | In distribution | |
| 6800835 | In distribution | |
| 6800845 | In distribution | |
| 6199456 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Validate | LGC Clinical Diagnostics, Inc. | 37 |
| Architect | Abbott Laboratories | 24 |
| Architect | Abbott Medical | 23 |
| BioPlex 2200 | Bio-Rad Laboratories Inc. | 22 |
| Architect | Abbott Ireland | 18 |
| Liquichek | Bio-Rad Laboratories Inc. | 17 |
| Alinity | Abbott Medical | 17 |
| Alinity | Abbott Ireland | 15 |
| Fora | Fora Care Inc. | 15 |
| Pregnancy-Skreen | Biochemical Diagnostics, Inc. | 14 |
| Accurun® | LGC Clinical Diagnostics, Inc. | 14 |
| Plasma Control | Chromsystems Instruments & Chemicals Gmbh | 9 |
Showing 12 of 907. All products under Single (Specified) Analyte Controls (Assayed And Unassayed)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K042303 | 2004-09-27 |
| K033127 | 2003-10-31 |
| K032993 | 2003-10-31 |
| K013900 | 2001-12-21 |
| K012561 | 2001-08-29 |
| K011250 | 2001-06-13 |
| K011463 | 2001-06-13 |
| K003112 | 2000-11-02 |
| K990984 | 1999-04-08 |
| K990783 | 1999-03-25 |
| K990026 | 1999-01-29 |
| K990061 | 1999-01-25 |
| K984011 | 1998-12-07 |
Recalls Naming This Product
3 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Ortho-Clinical Diagnostics, Inc. | UDI-DI | 2024-05-08 | Class III | Nonconforming Material/Component | The results generated by the VITROS Immunodiagnostic Products Vitamin B12 Range Verifier Lot# 1200 RV Level 2 may cause range verification failure. The issue is detectable by the user when the product fails to meet the required range during | 76 units | |
| Ortho-Clinical Diagnostics, Inc. | UDI-DI | 2023-05-18 | Class III | Under Investigation by firm | May not meet the stability specifications for shelf life outlined in the Instructions For Use (IFU). | 2 units | |
| Ortho-Clinical Diagnostics, Inc. | UDI-DI | 2021-10-15 | Class III | Under Investigation by firm | Ortho Clinical Diagnostics confirmed a complaint that some VITROS Immunodiagnostic Products Anti-HBc IgM Controls Lot 1690 Controls Values booklet contained information for the incorrect product. While the accuracy of patient test results i | 191 units | 2023-12-18 |
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.