Antiserum to Apolipoprotein A-1
Antiserum to Apolipoprotein A-1: 1 catalogue number listed by Kent Laboratories, Inc., United States, under Apolipoproteins. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
1catalogue number
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jilin (1), Shandong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Biobase Biodustry(Shandong)Co., Ltd. | Jinan | Shandong | Manufacturer | 70 |
Record
| Listed by | Kent Laboratories, Inc., United States |
|---|---|
| FDA product code | MSJ |
| Device type | Apolipoproteins |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1475 |
| Establishment | Manufacturer |
| 510(k) | K850691 |
| Record published | 2016-09-24 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Biobase | Biobase Biodustry(Shandong)Co., Ltd. | 42 |
| Synchron | Beckman Coulter, Inc. | 2 |
| Immage | Beckman Coulter, Inc. | 2 |
| Vitros | Ortho-Clinical Diagnostics, Inc. | 2 |
| Apolipoprotein A-I (APO A-I) | Randox Laboratories Limited | 1 |
| Antiserum to Apolipprotein B | Kent Laboratories, Inc. | 1 |
| Apolipoprotein B (APO B) | Randox Laboratories Limited | 1 |
| Apolipoprotein E (APO E) | Randox Laboratories Limited | 1 |
| Apolipoprotein C-II (APO C-II) | Randox Laboratories Limited | 1 |
| Mercodia Lp(a) Elisa | Mercodia AB | 1 |
| Atellica CH APO A1 | Siemens Healthcare Diagnostics Inc | 1 |
| Dimension Vista® Apolipoprotein AI Flex® reagent cartridge | Siemens Healthcare Diagnostics Products GmbH | 1 |
Showing 12 of 18. All products under Apolipoproteins
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K850690 | 1985-11-01 |
| K850691 | 1985-11-01 |
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.