LIO · Device, Specimen Collection
Microbiology · 21 CFR 866.2900 · Class 1
Overview
| Product Code | LIO |
|---|---|
| Device Name | Device, Specimen Collection |
| Regulation | 21 CFR 866.2900 |
| Device Class | Class 1 |
| Review Panel | Microbiology |
| 3rd-Party Reviewable | Yes |
Identification
A microbiological specimen collection and transport device is a specimen collecting chamber intended for medical purposes to preserve the viability or integrity of microorganisms in specimens during storage of specimens after their collection and during their transport from the collecting area to the laboratory. The device may be labeled or otherwise represented as sterile. The device aids in the diagnosis of disease caused by pathogenic microorganisms.
Classification Rationale
Class I (general controls). The device, when solely intended for use in the collection of concentrated parasites from specimens and transport, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.
Recent Cleared Devices (20 of 63)
Showing 20 most recent of 63 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K222613 | ARX Liquid Amies Collection & Transport System | Arx Sciences, Inc. | Mar 27, 2024 | SESE |
| K131630 | PURITAN AMIES MEDIUM COLLECTION AND TRANSPORT SYSTEM | Puritan Medical Products, LLC | Oct 21, 2013 | SESE |
| K120846 | TRANSPORT CULTURE MEDIUM DEVICE | Puritan Medical Products, LLC | Jun 8, 2012 | SESE |
| K103805 | MEDICAL WIRE & EQUIPMENT S-TRANSWAB (OR SIGMA-TRANSWAB) LIQUID AMIES COLLECTION AND TRANSPORT DEVICE | Medical Wire & Equipment Company (Bath), Ltd. | Jan 25, 2011 | SESE |
| K082472 | VIROCULT, MODEL MW950 | Medical Wire & Equipment Company (Bath), Ltd. | Dec 30, 2008 | SESE |
| K070062 | COPROSET SALMONELLA AND SHIGELLA, URISET PRESERVATIVE TUBES AND SWAB SET GENERAL USE | Diesse Diagnostica Senese S.P.A. | Jul 30, 2007 | SESE |
| K013711 | BACTI-SWAB DRY | Remel Co. | Nov 26, 2001 | SESE |
| K003761 | NAT - NUCLEIC ACID TRANSPORT | Medical Packaging Corp. | May 31, 2001 | SESE |
| K983119 | ENTERO-TEST HP, MODEL #102-01 | Hdc Corp. | Mar 15, 1999 | SESE |
| K981391 | PAR-ONE | Remel, Inc. | Jul 14, 1998 | SESE |
| K964144 | PARACON PLUS FORMALIN - PCP-F, PARACON PLUS SAF - PCP-SAF AND PARACON PLUS MF - PCP-MF | Para Scientific Co. | Nov 27, 1996 | SESE |
| K963986 | STP SYSTEM PVA WITH ZINC | Sage Products, Inc. | Nov 8, 1996 | SESE |
| K964026 | STP SYSTEM - SAF | Sage Products, Inc. | Nov 7, 1996 | SESE |
| K964027 | STP SYSTEM-PVA WITH MERCURY | Sage Products, Inc. | Nov 1, 1996 | SESE |
| K960997 | STARSWAB CULTURE COLLECTION AND TRANSPORT SYSTEM | Starplex Scientific, Inc. | Apr 3, 1996 | SESE |
| K953929 | MID-STREAM COLLECTION SET-STERILE | Trinity Laboratories, Inc. | Nov 16, 1995 | SESE |
| K950096 | PINWORM EGG COLLECTOR | Evergreen Industries, Inc. | Apr 5, 1995 | SESE |
| K931770 | PARA-PAK PLUS | Meridian Diagnostics, Inc. | Jun 15, 1993 | SESE |
| K931383 | ZINC PVA | Remel Co. | Jun 15, 1993 | SESE |
| K930313 | APEX SPECIMEN BAG | Apex Medical Technologies, Inc. | Mar 18, 1993 | SESE |
Top Applicants
- Pro-Lab Diagnostics — 4 clearances
- Remel Co. — 4 clearances
- Medical Laboratory Automation Systems, Inc. — 3 clearances
- Sage Products, Inc. — 3 clearances
- Bio-Rad — 2 clearances
