Validate
VALIDATE Fertility 4 Calibration Verification / Linearity Test Kit solutions are intended for in vitro diagnostic use in the determination of linearity, calibration verification and…
VALIDATE Fertility 4 Calibration Verification / Linearity Test Kit solutions are intended for in vitro diagnostic use in the determination of linearity, calibration verification and verification of reportable range in automated instrument systems for the following analyte: Placental growth factor (PlGF). VALIDATE Test Kits are non-automated and intended for laboratory professional use only. Each test kit consists of one bottle each of Levels 1 through 5. Each bottle contains 4.0 milliliters. There exists a linear relationship among Levels 1 through 5 for each set.
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 | LGC 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 | Specification developer, Manufacturer |
| 510(k) | K123127 |
| Record published | 2026-01-06 |
| Record revised | 2024-10-21 (version 3) |
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 |
| Storage | Storage environment temperature -25 to -10 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 807re | In distribution | |
| 605sa | 2 tests | In distribution |
| 304re | In distribution | |
| 510mm | In distribution | |
| 907re | In distribution | |
| 406re | 2 tests | In distribution |
| 406ab | In distribution | |
| 303ro | 2 tests | In distribution |
| 605to | 2 tests | In distribution |
| 506ro | In distribution | |
| 605 | 2 tests | In distribution |
| 503re | In distribution | |
| 506 | 2 tests | In distribution |
| 307 | 2 tests | In distribution |
| 803re | In distribution | |
| 405ab | 2 tests | In distribution |
| 806re | In distribution | |
| 509ro | 2 tests | In distribution |
| 302mm | 2 tests | In distribution |
| 801mm | In distribution | |
| 406bc | 2 tests | In distribution |
| 210re | In distribution | |
| 403ab | 2 tests | In distribution |
| 607ro | 2 tests | In distribution |
| 805re | In distribution | |
| 506vt | 2 tests | In distribution |
| 506ab | 2 tests | In distribution |
| 305re | In distribution | |
| 405re | In distribution | |
| 808re | In distribution | |
| 310ro | In distribution | |
| 403ro | 2 tests | In distribution |
| 804re | In distribution | |
| 609re | In distribution | |
| 511ro | In distribution | |
| 802re | In distribution | |
| 309re | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Vitros | Ortho-Clinical Diagnostics, Inc. | 55 |
| 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)
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.