Validate
VALIDATE CM3 Calibration Verification / Linearity Test Kit solutions are intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and…
VALIDATE CM3 Calibration Verification / Linearity Test Kit solutions are intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range in automated, semi-automated and manual instrument systems for the following analytes: homocysteine (HCY) and lipoprotein (a) (LP(a)). Each test kit consists of one bottle each of Levels 1 through 5. Each bottle contains 3.0 milliliters. There exists a linear relationship among Levels 1 through 5.
1manufacturer
120catalogue numbers in this listing
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Getein Biotech, Inc. | Nanjing | Jiangsu | Manufacturer | 19 |
Record
| Listed by | LGC Clinical Diagnostics, Inc., United States |
|---|---|
| FDA product code | JJY |
| Device type | Multi-Analyte Controls, All Kinds (Assayed) |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1660 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K041975 |
| Record published | 2020-11-12 |
| Record revised | 2024-05-13 (version 6) |
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 |
|---|---|---|
| 308vt | 2 tests | In distribution |
| 501db | 2 tests | In distribution |
| 1700 | 2 tests | In distribution |
| 705db | 2 tests | In distribution |
| 401db | 2 tests | In distribution |
| 203vt | 2 tests | In distribution |
| 203sd | 2 tests | In distribution |
| 1200vt | 2 tests | In distribution |
| 704db | 2 tests | In distribution |
| 104ab | 2 tests | In distribution |
| 501au | 2 tests | In distribution |
| 405ro | 2 tests | In distribution |
| 1004ro | In distribution | |
| 603ro | 2 tests | In distribution |
| 502ab | 2 tests | In distribution |
| 603ab | In distribution | |
| 602re | 2 tests | In distribution |
| 1100sd | 2 tests | In distribution |
| 901ab | 2 tests | In distribution |
| 501bc | 2 tests | In distribution |
| 601bcs | 2 tests | In distribution |
| 704ri | 2 tests | In distribution |
| 602ab | In distribution | |
| 701bc | 2 tests | In distribution |
| 701au | 2 tests | In distribution |
| 402ab | 2 tests | In distribution |
| 402re | 2 tests | In distribution |
| 601ab | 2 tests | In distribution |
| 1100ri | 2 tests | In distribution |
| 1100sa | 2 tests | In distribution |
| 408re | 2 tests | In distribution |
| 701ab | 2 tests | In distribution |
| 705ab | 2 tests | In distribution |
| 407re | 2 tests | In distribution |
| 409ro | 2 tests | In distribution |
| 601ro | 2 tests | In distribution |
| 1100sv | 2 tests | In distribution |
| 1100vt | 2 tests | In distribution |
| 901bc | 2 tests | In distribution |
| 1400sa | 2 tests | In distribution |
| 706af | 2 tests | In distribution |
| 1300vt | 2 tests | In distribution |
| 1200re | 2 tests | In distribution |
| 401ro | 2 tests | In distribution |
| 601bc | 2 tests | In distribution |
| 705ro | 2 tests | In distribution |
| 704sa | 2 tests | In distribution |
| 1001ro | In distribution | |
| 1100bc | 2 tests | In distribution |
| 401bc | 2 tests | In distribution |
| 608mm | In distribution | |
| 901re | 2 tests | In distribution |
| 1400re | 2 tests | In distribution |
| 701re | 2 tests | In distribution |
| 1002ro | In distribution | |
| 404ro | 2 tests | In distribution |
| 1300re | 2 tests | In distribution |
| 1400ab | 2 tests | In distribution |
| 704bc | 2 tests | In distribution |
| 204ro | 2 tests | In distribution |
| 1300ab | 2 tests | In distribution |
| 206ro | 2 tests | In distribution |
| 1400ri | 2 tests | In distribution |
| 402vt | 2 tests | In distribution |
| 504ab | 2 tests | In distribution |
| 705au | 2 tests | In distribution |
| 602bc | 2 tests | In distribution |
| 1200bc | 2 tests | In distribution |
| 1200ab | 2 tests | In distribution |
| 1400sd | 2 tests | In distribution |
| 402pf | In distribution | |
| 203ro | 2 tests | In distribution |
| 1300sa | 2 tests | In distribution |
| 701ri | 2 tests | In distribution |
| 308bc | 2 tests | In distribution |
| 502re | 2 tests | In distribution |
| 701sa | 2 tests | In distribution |
| 704ro | 2 tests | In distribution |
| 401ab | 2 tests | In distribution |
| 1100ro | 2 tests | In distribution |
| 705bcc | 2 tests | In distribution |
| 1300sd | 2 tests | In distribution |
| 507ro | 2 tests | In distribution |
| 1100wa | In distribution | |
| 701ro | 2 tests | In distribution |
| 1300wa | In distribution | |
| 701db | 2 tests | In distribution |
| 205bf | 2 tests | In distribution |
| 501ro | 2 tests | In distribution |
| 207ro | In distribution | |
| 703 | 2 tests | In distribution |
| 402bc | 2 tests | In distribution |
| 1400au | 2 tests | In distribution |
| 1400bc | 2 tests | In distribution |
| 704au | 2 tests | In distribution |
| 1300au | 2 tests | In distribution |
| 1200sd | 2 tests | In distribution |
| 501ab | 2 tests | In distribution |
| 705ri | 2 tests | In distribution |
| 705vt | 2 tests | In distribution |
| 501sa | 2 tests | In distribution |
| 704ab | 2 tests | In distribution |
| 1003ro | In distribution | |
| 508ro | In distribution | |
| 308ab | 2 tests | In distribution |
| 205ro | 2 tests | In distribution |
| 1400vt | 2 tests | In distribution |
| 505ro | 2 tests | In distribution |
| 1200au | 2 tests | In distribution |
| 308re | 2 tests | In distribution |
| 701vt | 2 tests | In distribution |
| 1100au | 2 tests | In distribution |
| 1100ab | 2 tests | In distribution |
| 1200sa | 2 tests | In distribution |
| 501vt | 2 tests | In distribution |
| 407sa | 2 tests | In distribution |
| 504re | 2 tests | In distribution |
| 1300bcc | 2 tests | In distribution |
| 407ab | 2 tests | In distribution |
| 908bc | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Liquichek | Bio-Rad Laboratories Inc. | 154 |
| 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 |
| Rap/Tac/CsA Control | More Diagnostics Inc. | 12 |
Showing 12 of 559. All products under Multi-Analyte Controls, All Kinds (Assayed)
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.