Bactigen H. Influenzae Type B

No FDA recalls on record, checked 6 Oct 2026.

Full name

Bactigen(R) H. Influenzae Type B

510(k) Number

K884967 ↗

FDA Product Code

GRP

Device Class

Class II

Regulation

21 CFR Part 866.3300

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Positive & Negative Hcg Urine Controls

  Class I

  FDA 510(k) K821742 Active Cleared 2 Jul 1982

• Bactogen-H. Influenzae Type B

  Class II

  FDA 510(k) K800493 Active Cleared 4 Apr 1980

• Bactigen(R) Group B Streptococcus Test

  Class I

  FDA 510(k) K885003 Active Cleared 7 Feb 1989

• Trojan Naturalamb Natural Membrane Condom W/Sperm.

  Class II

  FDA 510(k) K902305 Active Cleared 29 Mar 1991

• Bactigen Group B Streptococcus Test

  Class I

  FDA 510(k) K850772 Active Cleared 29 May 1985

• Brand Name 1-Step Pregnancy Test-May Be Marketed Under First Response, Answer, or Other Brand Names

  Class II

  FDA 510(k) K962183 Active Cleared 10 Jul 1996

See all devices from Armkel, LLC →

• What is the BACTIGEN H. Influenzae Type B device used for?

  BACTIGEN H. Influenzae Type B is an antisera device specifically designed for the detection of Haemophilus influenzae type B in laboratory settings. It helps identify this specific bacterial strain in microbiological testing.

• How is the BACTIGEN H. Influenzae Type B device supplied?

  The device is supplied as a Class II medical device with FDA 510(k) clearance under product code GRP. It is manufactured by Armkel, LLC and is regulated under 866.3300. The device is not specified as single-use or reusable.

• What regulatory approvals does the BACTIGEN H. Influenzae Type B device have?

  The device has FDA 510(k) clearance with the K number K884967. It was received by the FDA on November 30, 1988, and cleared on February 7, 1989. It is classified under microbiology and is substantially equivalent to predicate devices.

• What are the specifications of the BACTIGEN H. Influenzae Type B device?

  The device is classified as a Class II medical device with product code GRP. It is manufactured by Armkel, LLC in Cranbury, NJ. The device is designed for laboratory use and is not specified for MRI compatibility. No specific sizes or models are mentioned in the device data.