JCO · Bothrops Atrox Reagent
Hematology · 21 CFR 864.8100 · Class 2
Overview
| Product Code | JCO |
|---|---|
| Device Name | Bothrops Atrox Reagent |
| Regulation | 21 CFR 864.8100 |
| Device Class | Class 2 |
| Review Panel | Hematology |
| 3rd-Party Reviewable | Yes |
Identification
A Bothrops atrox reagent is a device made from snake venom and used to determine blood fibrinogen levels to aid in the evaluation of disseminated intravascular coagulation (nonlocalized clotting in the blood vessels) in patients receiving heparin therapy (the administration of the anticoagulant heparin in the treatment of thrombosis) or as an aid in the classification of dysfibrinogenemia (presence in the plasma of functionally defective fibrinogen).
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (7 of 7)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K955115 | VENOM TIEM REAGENT | Medical Diagnostic Technologies, Inc. | Apr 3, 1996 | SESE |
| K932787 | BATROXOBIN REAGENT | Behring Diagnostics, Inc. | Nov 29, 1993 | SESE |
| K896033 | FDP COLLECTION TUBES | Medical Diagnostic Technologies, Inc. | Oct 27, 1989 | SESE |
| K852519 | DUPONT ACA FIBRIN DEGRADATION PROD CLOTTING TUBE | E.I. Dupont DE Nemours & Co., Inc. | Aug 12, 1985 | SESE |
| K843207 | REPTILASE -PC | Bio/Data Corp. | Oct 23, 1984 | SESE |
| K840210 | REPTILASE-R HA35 | Wellcome Diagnostics | Apr 23, 1984 | SESE |
| K780355 | ATROXIN | Sigma Chemical Co. | Apr 18, 1978 | SESE |
Top Applicants
- Medical Diagnostic Technologies, Inc. — 2 clearances
- Behring Diagnostics, Inc. — 1 clearance
- Bio/Data Corp. — 1 clearance
- E.I. Dupont DE Nemours & Co., Inc. — 1 clearance
- Sigma Chemical Co. — 1 clearance
