Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart B — Diagnostic Devices](/submissions/AN/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 868.1100](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/868.1100) → OFZ — Blood Specimen Collection Kit (Excludes Hiv Testing)

# OFZ · Blood Specimen Collection Kit (Excludes Hiv Testing)

_Anesthesiology · 21 CFR 868.1100 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/OFZ

## Overview

- **Product Code:** OFZ
- **Device Name:** Blood Specimen Collection Kit (Excludes Hiv Testing)
- **Regulation:** [21 CFR 868.1100](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/868.1100)
- **Device Class:** 1
- **Review Panel:** [Anesthesiology](/submissions/AN)

## Identification

An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations. The kit may include a syringe, needle, cork, and heparin.

## Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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**Source:** [https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/OFZ](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/OFZ)

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