Multichem AE
20 catalogue numbers from AE611X, listed by Techno-Path Manufacturing Ltd., Ireland, under Multi-Analyte Controls, All Kinds (Assayed). 1 manufacturer in China is registered for this product code.
1manufacturer
20catalogue numbers in this listing
5510(k) clearances naming this product code
3recalls 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 | Techno-Path Manufacturing Ltd., Ireland |
|---|---|
| FDA product code | JJY |
| Device type | Multi-Analyte Controls, All Kinds (Assayed) |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1660 |
| Establishment | Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2022-09-16 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AE611X | In distribution | |
| AE610A | In distribution | |
| AE602X | In distribution | |
| AE610X | In distribution | |
| 06S7861 | In distribution | |
| AE601A | In distribution | |
| AE600A | In distribution | |
| AE601X | In distribution | |
| AE613A | In distribution | |
| AE600X | In distribution | |
| AE612A | In distribution | |
| AE623A | In distribution | |
| 06S7862 | In distribution | |
| AE602A | In distribution | |
| AE611A | In distribution | |
| 06S7863 | In distribution | |
| AE612X | In distribution | |
| AE622A | In distribution | |
| AE613X | In distribution | |
| AE621A | 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 |
| 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)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K162530 | 2017-03-31 |
| K132751 | 2013-10-22 |
| K131993 | 2013-10-15 |
| K131992 | 2013-09-25 |
| K132091 | 2013-09-20 |
Recalls
3 of these are 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 |
|---|---|---|---|---|
| 2023-08-25 | Class II | Unknown/Undetermined by firm | Technopath Manufacturing Ltd. has identified an issue with the glass vial commodity used to fill the Multichem S Plus Level 1, Multichem S Plus Level 2, Multichem S Plus Level 3, Multichem IA Plus and Multichem P Controls. Some customers ha | 41455 units |
| 2023-08-25 | Class II | Unknown/Undetermined by firm | Technopath Manufacturing Ltd. has identified an issue with the glass vial commodity used to fill the Multichem S Plus Level 1, Multichem S Plus Level 2, Multichem S Plus Level 3, Multichem IA Plus and Multichem P Controls. Some customers ha | 2964 units |
| 2023-08-25 | Class II | Unknown/Undetermined by firm | Technopath Manufacturing Ltd. has identified an issue with the glass vial commodity used to fill the Multichem S Plus Level 1, Multichem S Plus Level 2, Multichem S Plus Level 3, Multichem IA Plus and Multichem P Controls. Some customers ha | 117155 units |
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.