FastPack® Control Kit
FastPack Control Kit is an assayed quality-control material for checking accuracy and precision on FastPack and FastPack IP systems. It covers free thyroxine, hCG, testosterone, total…
FastPack Control Kit is an assayed quality-control material for checking accuracy and precision on FastPack and FastPack IP systems. It covers free thyroxine, hCG, testosterone, total prostate-specific antigen and thyroid-stimulating hormone assays.
The controls are supplied as liquids in a synthetic matrix containing human-origin and synthesized analyte constituents, with chemicals, preservatives and stabilizers. Each kit contains one 5 mL vial at Level 1 and one at Level 2.
Listed Item
Two control levels for the following assays: TPSA, Testo, FT4, TSH, hCG
Storage
Unopened controls have a specified shelf life of 18 months at 2 to 8°C. Once opened, the stated stability is 120 days at the same refrigerated temperature.
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Getein Biotech, Inc. | Nanjing | Jiangsu | Manufacturer | 19 |
Record
| Listed by | Qualigen, 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 | Complaint-file establishment, Manufacturer |
| 510(k) | K123725 |
| Record published | 2016-09-16 |
| Record revised | 2022-12-08 (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 |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Multi-Analyte Controls | 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 |
|---|---|
| K123725 | 2013-03-08 |
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.