Home › STANBIO LABORATORY, L.P. › Nitro-tab Ketone Tablets
Nitro-tab Ketone Tablets
STANBIO LABORATORY, L.P. · Model 4000-100 · UDI-DI 00657498002131
JIN
Prescription
10
510(k) clearances
187
Adverse events (1 deaths)
14
Recalls
102
Facilities
Description
Nitro-tab Ketone Tablets are for the semi-quantitative determination of ketones (acetoacetic acid and acetone) in urine, serum, plasma, and whole blood.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-04-02 | DFI Co., Ltd. | The devices were distributed without required FDA premarket clearance or approval. |
| 2025-11-22 | Changchun Wancheng Bio-Electron Co., Ltd. | Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause fa |
| 2023-10-02 | Stanbio Laboratory, LP | Deterioration in the stability of the Test Strips results in diminished low-range detection capability and inability to meet linearity performance claims. The root cause of the sta |
| 2023-05-22 | Universal Meditech Inc. | Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Stri |
| 2023-05-22 | Universal Meditech Inc. | Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Stri |
| 2022-03-08 | MEDLINE INDUSTRIES, LP - Northfield | Product was improperly store which may cause a delay in results. |
| 2021-07-12 | Stanbio Laboratory, LP | Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values. |
| 2021-07-12 | Stanbio Laboratory, LP | Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values. |
| 2021-07-12 | Stanbio Laboratory, LP | Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values. |
| 2021-07-12 | Stanbio Laboratory, LP | Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.