Auto-Lyte
Auto-Lyte Cotinine Urine 1000mL
2manufacturers in China registered for this device type
2catalogue numbers in this listing
3510(k) clearances naming this product code
Who Else Makes It
All of them in Zhejiang. 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Orient Gene Biotech | Huzhou | Zhejiang | Contract manufacturer | 86 |
| Hangzhou Biotest Biotech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 41 |
Record
| Listed by | Orasure Technologies, Inc., United States |
|---|---|
| FDA product code | MKU |
| Device type | Enzyme Immunoassay, Nicotine And Nicotine Metabolites |
| Device class | Class 1 |
| Regulation | 21 CFR 862.3220 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2016-04-29 |
| Record revised | 2026-05-05 (version 4) |
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 |
| Distribution end date | 2025-04-04 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1224UM | Withdrawn | |
| 1224UL | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DRI Cotinine Assay | Microgenics Corporation | 3 |
| LZI Cotinine II Enzyme Immunoassay | LIN-ZHI International, Inc. | 2 |
| DRI Cotinine Low Control | Microgenics Corporation | 1 |
| Kit, MP Cotinine Serum 100 plate | Orasure Technologies, Inc. | 1 |
| Nano-CheckTM Nicotine 500 | Nano-Ditech Corporation | 1 |
| Cotinine Serum 5 Plate Kit | Orasure Technologies, Inc. | 1 |
| AccuSign® Nicotine card | Princeton BioMeditech Corp. | 1 |
| DRI Cotinine High Control | Microgenics Corporation | 1 |
| Cotinine OraSure 100 Plate Kit | Orasure Technologies, Inc. | 1 |
| SureStep™ Urine Test Drug Screen Cassette, Cotinine (COT 200) | Alere San Diego, Inc. | 1 |
| DRI Cotinine Calibrator Kit | Microgenics Corporation | 1 |
| Cotinine OraSure 5 Plate Kit | Orasure Technologies, Inc. | 1 |
Showing 12 of 17. All products under Enzyme Immunoassay, Nicotine And Nicotine Metabolites
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K974534 | 1998-05-18 |
| K974234 | 1998-05-14 |
| K972481 | 1997-10-21 |
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.