Optilite Low Level Albumin Kit
Optilite Low Level Albumin Kit measures albumin in cerebrospinal fluid, urine and serum using the Binding Site Optilite analyser. The laboratory test aids diagnosis of kidney and intestinal…
Optilite Low Level Albumin Kit measures albumin in cerebrospinal fluid, urine and serum using the Binding Site Optilite analyser. The laboratory test aids diagnosis of kidney and intestinal diseases, with results interpreted alongside other laboratory and clinical findings.
The assay uses antibodies that react with albumin to form insoluble complexes. These make the sample suspension more turbid and reduce the light passing through it. The analyser measures transmitted light and calculates albumin concentration against a stored calibration curve.
Kit Reagents
The kit contains a liquid antiserum reagent, reaction buffer, calibrator and controls. Antiserum and buffer occupy separate chambers of a single reagent wedge. The detection antibody is sheep anti-human albumin.
Who Else Makes It
Concentrated in Jilin (1), Hunan (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| AVE Science & Technology Co., Ltd. | Changsha | Hunan | Manufacturer | 22 |
Record
| Listed by | The Binding Site Group Ltd., United Kingdom |
|---|---|
| FDA product code | DCF |
| Device type | Albumin, Antigen, Antiserum, Control |
| Device class | Class 2 |
| Regulation | 21 CFR 866.5040 |
| Establishment | Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K153560 |
| Record published | 2017-06-07 |
| Record revised | 2025-08-18 (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 |
|---|---|---|
| NK032.L.OPT.A | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ortho | Ortho-Clinical Diagnostics, Inc. | 4 |
| JAS Diagnostics | Drew Scientific, Ltd. | 2 |
| N Antiserum to Human Albumin | Siemens Healthcare Diagnostics Products GmbH | 2 |
| AU | Beckman Coulter, Inc. | 2 |
| Albumin LiquiColor® | Stanbio Laboratory, L.P. | 1 |
| Microalbumin Assay | Sekisui Diagnostics, LLC | 1 |
| K-Assay® Microalbumin Reagent (L) | Kamiya Biomedical Company LLC | 1 |
| Human Albumin CSF Kit for use on Spaplus | The Binding Site Group Ltd. | 1 |
| Microalbuminuria Kit (Immunoturbidimetric Method) | Medicalsystem Biotechnology Co., Ltd. | 1 |
| Yumizen C1200 Albumin U/CSF | Horiba ABX SAS | 1 |
| Microalbumin | Sekisui Diagnostics, LLC | 1 |
| Synchron | Beckman Coulter, Inc. | 1 |
Showing 12 of 35. All products under Albumin, Antigen, Antiserum, Control
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K153560 | 2016-08-25 |
| K143118 | 2015-05-26 |
| K121045 | 2013-06-19 |
| K914391 | 1991-12-10 |
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.