Architect
ARCHITECT HAVAB-G Reagent Kit
1manufacturer
2catalogue numbers in this listing
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Minlong Pharmaceutical Biotechnology (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Repacker / relabeller | 21 |
Record
| Listed by | Abbott Medical, United States |
|---|---|
| FDA product code | MJY |
| Device type | Kit, Serological, Negative Control |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1660 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K113704 |
| Record published | 2016-09-09 |
| Record revised | 2024-02-21 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| 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 |
|---|---|---|
| 6L27-25 | In distribution | |
| 6L27-10 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Access HIV Ag/Ab combo QC | Beckman Coulter, Inc. | 1 |
| Serology Lyme Disease Negative Control (Lyme Control -) | Randox Laboratories Limited | 1 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Abbott Medical | 510(k) number | 2020-03-09 | Class II | Mixed-up of materials/components | An erroneous concentration value for hepatitis A virus was utilized during manufacture, leading to a decreased amount of antigen used for the impacted lots. | 7,347 kits | 2021-02-11 |
| Abbott Medical | 510(k) number | 2019-11-07 | Class II | Material/Component Contamination | Abbott has identified that Calibrator lot 08219BE00 is potentially impacted by an increase in Relative Light Units (RLUs) up to 94%. It has been confirmed that the increase in the calibrator RLU values may cause a decrease in the control va | 83 kits | 2023-08-31 |
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.