Carolina Liquid Chemistries Corp.® Etha RGT. KIT ST421
ETHA (Alcohol) w/ cal 3 x 375 tests
2manufacturers in China registered for this device type
1catalogue number
2recalls on this code
Who Else Makes It
Concentrated in Zhejiang (1), Guangdong (1). 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 |
| Guangzhou Wondfo Biotech Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 44 |
Record
| Listed by | Carolina Liquid Chemistries, United States |
|---|---|
| FDA product code | DIC |
| Device type | Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method |
| Device class | Class 2 |
| Regulation | 21 CFR 862.3040 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2016-09-01 |
| Record revised | 2023-08-14 (version 3) |
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 | Special storage condition: Reagent is stable when stored at 2-8° C until expiration date; Storage environment temperature 2 to 8 °C |
| Sizes | Total volume 5 to 63 ml |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ST421 | Total Volume 26 ml | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Immunalysis | Immunalysis Corporation | 4 |
| Wondfo | Wondfo USA Co., Ltd. | 4 |
| Ethanol Gen.2 | Roche Diagnostics Gmbh | 2 |
| Ethyl Alcohol Enzymatic Assay | LIN-ZHI International, Inc. | 2 |
| Wondfo Saliva Alcohol Test | Wondfo USA Co., Ltd. | 2 |
| Pointe Ethyl Alcohol Reagent Set | Horiba Instruments Incorporated | 2 |
| Pointe Scientific Alcohol | Horiba Instruments Incorporated | 2 |
| co-innovation | Co-Innovation Biotech Co., Ltd. | 1 |
| Ethanol Gen2 | Roche Diagnostics Gmbh | 1 |
| Teco Diagnostics | Teco Diagnostics | 1 |
| Atellica CH Ethanol (EtohC) | Siemens Healthcare Diagnostics Inc | 1 |
| MP Saliva Alcohol Test Strip | Rapid Diagnostics, Inc. | 1 |
Showing 12 of 27. All products under Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
Recalls
2 of these are Class III. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2019-01-16 | Class III | Nonconforming Material/Component | Supplier testing showed that the absorbance rate of the Ethyl Alcohol Assay did not meet internal quality control specifications. The defective lots will not function toward the end of shelf life. | 20 kits | 2021-02-02 |
| 2019-01-16 | Class III | Nonconforming Material/Component | 14 kits | 2021-02-02 |
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.