KSF · Kit, Quality Control For Blood Banking Reagents
Hematology · 21 CFR 864.9650 · Class 2
Overview
| Product Code | KSF |
|---|---|
| Device Name | Kit, Quality Control For Blood Banking Reagents |
| Regulation | 21 CFR 864.9650 |
| Device Class | Class 2 |
| Review Panel | Hematology |
Identification
A quality control kit for blood banking reagents is a device that consists of sera, cells, buffers, and antibodies used to determine the specificity, potency, and reactivity of the cells and reagents used for blood banking.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (12 of 12)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K811713 | AVI-D CONTROL | Ortho Diagnostic Systems, Inc. | Oct 23, 1981 | SESE |
| K810599 | DADE RH CONTROL REAGENT | American Dade | Mar 31, 1981 | SESE |
| K801425 | RH CONTROL | North American Biologicals, Inc. | Jul 14, 1980 | SESE |
| K800658 | RST-SERIES CONTROL | Gamma Biologicals, Inc. | Apr 16, 1980 | SESE |
| K800310 | ORTHO ANTISERA CONTROL | Ortho Diagnostics, Inc. | Mar 5, 1980 | SESE |
| K800239 | RH-HR NEGATIVE CONTROL REAGENT | Gotham Biologics, Inc. | Feb 21, 1980 | SESE |
| K790249 | TEST CELLS | Hyland Therapeutic Div., Travenol Laboratories | May 16, 1979 | SESE |
| K790025 | COUNTER CHECK, H001, H002, H003 | Diagnostic Technology, Inc. | Jan 17, 1979 | SESE |
| K780665 | RECAP | Bca Biological Corp. of America | Jun 6, 1978 | SESE |
| K780097 | QUALITY CONTROL SYSTEM, SPECTRA | Bd Becton Dickinson Vacutainer Systems Preanalytic | Apr 24, 1978 | SESE |
| K771814 | REAGENT CONFIDENCE SERA | Ortho Diagnostics, Inc. | Nov 7, 1977 | SESE |
| K761284 | UNIVAL CONTROL CELLS | Dade, Baxter Travenol Diagnostics, Inc. | Jan 25, 1977 | SESE |
Top Applicants
- Ortho Diagnostics, Inc. — 2 clearances
- American Dade — 1 clearance
- Bca Biological Corp. of America — 1 clearance
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 1 clearance
- Dade, Baxter Travenol Diagnostics, Inc. — 1 clearance
