Rapid Response 11 Parameter Urinalysis Reagent Strips (ASC/GLU/BLD/LEU/PRO/NIT/KET/PH/BIL/URO/SG) - 100 tests/ kit are for qualitative or semi-quantitative determination of Ascorbic Acid,…
Rapid Response 11 Parameter Urinalysis Reagent Strips (ASC/GLU/BLD/LEU/PRO/NIT/KET/PH/BIL/URO/SG) – 100 tests/ kit are for qualitative or semi-quantitative determination of Ascorbic Acid, Glucose, Blood, Leukocyte, Protein, Nitrite, Ketone, pH, Bilirubin, Urobilinogen, Specific Gravity in urine.
Who Else Makes It
Concentrated in Jilin (5), Zhejiang (2), Guangxi (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
Record
Regulatory record for Rapid Response | Listed by | Btnx Inc., Canada |
| FDA product code | JMA |
| Device type | Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1095 |
| Establishment | Repacker / relabeller, Private-label distributor, Complaint-file establishment, Exporter |
| 510(k) | K061559 |
| Record published | 2020-12-14 |
| Record revised | 2023-04-20 (version 4) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
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.