Bothrops Atrox Reagent
Bothrops atrox reagent is derived from the venom of the lancehead pit viper and is used in coagulation laboratory testing as a thrombin-like enzyme to assess fibrinogen levels and clot formation, particularly useful in patients on heparin anticoagulation. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance before marketing. The product code is JCO, regulated under 21 CFR 864.8100, within the Hematology medical specialty. This device is eligible for third-party review.
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Basic Information
- Product Code
- JCO
- Device Class
- FDA class 2
- Regulation Number
- 864.8100
- Medical Specialty
- Hematology
- Review Panel
- HE
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 7 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K955115 | VENOM TIEM REAGENT | Apr 03, 1996 | Substantially Equivalent | Medical Diagnostic Technologies, Inc. |
| K932787 | BATROXOBIN REAGENT | Nov 29, 1993 | Substantially Equivalent | Behring Diagnostics, Inc. |
| K896033 | FDP COLLECTION TUBES | Oct 27, 1989 | Substantially Equivalent | Medical Diagnostic Technologies, Inc. |
| K852519 | DUPONT ACA FIBRIN DEGRADATION PROD CLOTTING TUBE | Aug 12, 1985 | Substantially Equivalent | E.I. Dupont DE Nemours & Co., Inc. |
| K843207 | REPTILASE -PC | Oct 23, 1984 | Substantially Equivalent | Bio/Data Corp. |
| K840210 | REPTILASE-R HA35 | Apr 23, 1984 | Substantially Equivalent | Wellcome Diagnostics |
| K780355 | ATROXIN | Apr 18, 1978 | Substantially Equivalent | Sigma Chemical Co. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.