BIOPHEN NORMAL AND ABNORMAL CONTROL PLASMA - Biophen Normal And Abnormal Control Plasma
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K043451 FDA 510(k)
- FDA Product Code
- GGN FDA 510(k)
- Models / Variants
- Biophen Normal And Abnormal Control Plasma FDA 510(k)Biophen Plasma Calibrator FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 864.5425 FDA 510(k)
- Regulation Number
- 864.5425 FDA 510(k)
- Advisory Committee
- Hematology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Biophen Normal And Abnormal Control Plasma and Biophen Plasma Calibrator are plasma controls used in coagulation testing. They are classified as a Plasma, Coagulation Control device. The device is used in the field of Hematology. It is a type of control plasma used to calibrate and verify the performance of coagulation testing instruments.
The device is supplied by Hyphen Biomed and has been authorized with an FDA 510K clearance. The device has a regulation number of 864.5425 and is classified as a class 2 device. It is used in a laboratory setting and is intended for use as a control material in coagulation testing. The device is associated with various fei numbers and registration numbers, and its storage and handling requirements are not specified in the provided data.
Frequently asked questions
What is the Biophen Normal and Abnormal Control Plasma and Biophen Plasma Calibrator used for?
The device is used as a control material in coagulation testing to calibrate and verify the performance of coagulation testing instruments, ensuring accurate and reliable test results in hematology laboratories.
How is the Biophen Normal and Abnormal Control Plasma and Biophen Plasma Calibrator supplied?
The device is supplied by Hyphen Biomed as plasma controls intended for use in laboratory settings, though specific packaging, volume, or format details are not provided in the available data.
Is the Biophen Normal and Abnormal Control Plasma and Biophen Plasma Calibrator sterile or single-use?
The provided data does not specify whether the device is sterile, single-use, or reusable; therefore, no conclusion can be drawn about its sterility or reuse status based on the available information.
What sizes or models are available for the Biophen Normal and Abnormal Control Plasma and Biophen Plasma Calibrator?
The device data does not list specific sizes, models, or reference numbers beyond the product name; thus, no details on available sizes or model variations can be provided from the given information.
What are the storage and handling requirements for the Biophen Normal and Abnormal Control Plasma and Biophen Plasma Calibrator?
Storage and handling requirements for the device are not specified in the provided data, so no specific conditions such as temperature, light exposure, or stability details can be confirmed.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K043451 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hyphen Biomed
Sources (1)
- FDA 510(k) K043451 24 fields · synced Sep 23, 2026