Browse hierarchy: [Hematology (HE)](/submissions/HE) → [Subpart J — Products Used In Establishments That Manufacture Blood and Blood Products](/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products) → [21 CFR 864.9650](/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/864.9650) → KSF — Kit, Quality Control For Blood Banking Reagents

# KSF · Kit, Quality Control For Blood Banking Reagents

_Hematology · 21 CFR 864.9650 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSF

## Overview

- **Product Code:** KSF
- **Device Name:** Kit, Quality Control For Blood Banking Reagents
- **Regulation:** [21 CFR 864.9650](/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/864.9650)
- **Device Class:** 2
- **Review Panel:** [Hematology](/submissions/HE)

## 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](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSF/K811713.md) | AVI-D CONTROL | Ortho Diagnostic Systems, Inc. | Oct 23, 1981 | SESE |
| [K810599](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSF/K810599.md) | DADE RH CONTROL REAGENT | American Dade | Mar 31, 1981 | SESE |
| [K801425](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSF/K801425.md) | RH CONTROL | North American Biologicals, Inc. | Jul 14, 1980 | SESE |
| [K800658](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSF/K800658.md) | RST-SERIES CONTROL | Gamma Biologicals, Inc. | Apr 16, 1980 | SESE |
| [K800310](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSF/K800310.md) | ORTHO ANTISERA CONTROL | Ortho Diagnostics, Inc. | Mar 5, 1980 | SESE |
| [K800239](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSF/K800239.md) | RH-HR NEGATIVE CONTROL REAGENT | Gotham Biologics, Inc. | Feb 21, 1980 | SESE |
| [K790249](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSF/K790249.md) | TEST CELLS | Hyland Therapeutic Div., Travenol Laboratories | May 16, 1979 | SESE |
| [K790025](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSF/K790025.md) | COUNTER CHECK, H001, H002, H003 | Diagnostic Technology, Inc. | Jan 17, 1979 | SESE |
| [K780665](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSF/K780665.md) | RECAP | Bca Biological Corp. of America | Jun 6, 1978 | SESE |
| [K780097](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSF/K780097.md) | QUALITY CONTROL SYSTEM, SPECTRA | Bd Becton Dickinson Vacutainer Systems Preanalytic | Apr 24, 1978 | SESE |
| [K771814](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSF/K771814.md) | REAGENT CONFIDENCE SERA | Ortho Diagnostics, Inc. | Nov 7, 1977 | SESE |
| [K761284](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSF/K761284.md) | 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

---

**Source:** [https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSF](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSF)

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