Product code LIO
- Device name
- Device, Specimen Collection
- Medical specialty
- Microbiology
- Device class
- 1
- Regulation number
- 866.2900
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K222613 | ARX Liquid Amies Collection & Transport System | Arx Sciences, Inc. | 2024-03-27 |
| K131630 | PURITAN AMIES MEDIUM COLLECTION AND TRANSPORT SYSTEM | Puritan Medical Products, LLC | 2013-10-21 |
| K120846 | TRANSPORT CULTURE MEDIUM DEVICE | Puritan Medical Products, LLC | 2012-06-08 |
| K103805 | MEDICAL WIRE & EQUIPMENT S-TRANSWAB (OR SIGMA-TRANSWAB) LIQUID AMIES COLLECTION AND TRANSPORT DEVICE | Medical Wire & Equipment Company (Bath), Ltd. | 2011-01-25 |
| K082472 | VIROCULT, MODEL MW950 | Medical Wire & Equipment Company (Bath), Ltd. | 2008-12-30 |
| K070062 | COPROSET SALMONELLA AND SHIGELLA, URISET PRESERVATIVE TUBES AND SWAB SET GENERAL USE | Diesse Diagnostica Senese S.P.A. | 2007-07-30 |
| K013711 | BACTI-SWAB DRY | Remel Co. | 2001-11-26 |
| K003761 | NAT - NUCLEIC ACID TRANSPORT | Medical Packaging Corp. | 2001-05-31 |
| K983119 | ENTERO-TEST HP, MODEL #102-01 | Hdc Corp. | 1999-03-15 |
| K981391 | PAR-ONE | Remel, Inc. | 1998-07-14 |
| K964144 | PARACON PLUS FORMALIN - PCP-F, PARACON PLUS SAF - PCP-SAF AND PARACON PLUS MF - PCP-MF | Para Scientific Co. | 1996-11-27 |
| K963986 | STP SYSTEM PVA WITH ZINC | Sage Products, Inc. | 1996-11-08 |
| K964026 | STP SYSTEM - SAF | Sage Products, Inc. | 1996-11-07 |
| K964027 | STP SYSTEM-PVA WITH MERCURY | Sage Products, Inc. | 1996-11-01 |
| K960997 | STARSWAB CULTURE COLLECTION AND TRANSPORT SYSTEM | Starplex Scientific, Inc. | 1996-04-03 |
| K953929 | MID-STREAM COLLECTION SET-STERILE | Trinity Laboratories, Inc. | 1995-11-16 |
| K950096 | PINWORM EGG COLLECTOR | Evergreen Industries, Inc. | 1995-04-05 |
| K931770 | PARA-PAK PLUS | Meridian Diagnostics, Inc. | 1993-06-15 |
| K931383 | ZINC PVA | Remel Co. | 1993-06-15 |
| K930313 | APEX SPECIMEN BAG | Apex Medical Technologies, Inc. | 1993-03-18 |
| K924053 | CYTOQUANT COMBINED TRANSPORT MEDIA | Proteins Intl., Inc. | 1993-01-15 |
| K924329 | TRANSYSTEM AMIES W/O CHARCOAL | Pro-Lab Diagnostics | 1992-12-24 |
| K924328 | TRANSYSTEM LIQUID AMIES MEDIUM | Pro-Lab Diagnostics | 1992-12-24 |
| K924330 | TRANSYSTEM AMIES WITH CHARCOAL | Pro-Lab Diagnostics | 1992-12-24 |
| K924331 | TRANSYSTEM LIQUID STUART MEDIUM | Pro-Lab Diagnostics | 1992-12-24 |
| K920536 | AFFIRM VP SAMPLE COLLECTION SET | Microprobe Corp. | 1992-07-30 |
| K920761 | URINE CULTUR STABILIZATION TRANSPORT TUBE | Bio Medicus, Inc. | 1992-06-19 |
| K915454 | CHLAMYDIA TRACHOMATIS SPECIMEN COLLECTION KIT | Medical Packaging Corp. | 1992-04-08 |
| K912832 | BACTI-SWAB(TM) NPG | Remel Co. | 1991-08-22 |
| K912831 | BACTI-SWAB(TM) II | Remel Co. | 1991-07-30 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07898996204631 | Viral Transport Media (VTM) 3ml | A. L. B. LUZ | 2024-07-23 |
| 28053326002209 | FecalSwab® | COPAN ITALIA SPA | 2024-05-07 |
| 30609576900014 | Puritan UniTranz-RT | Puritan Medical Products | 2022-12-08 |
| 30609576900007 | Puritan UniTranz-RT | Puritan Medical Products | 2022-12-08 |
| 30609576900021 | Puritan UniTranz-RT | Puritan Medical Products | 2022-12-08 |
| 30609576900038 | Puritan UniTranz-RT | Puritan Medical Products | 2022-12-08 |
| 30609576900045 | Puritan UniTranz-RT | Puritan Medical Products | 2022-12-08 |
| 30609576900052 | Puritan UniTranz-RT | Puritan Medical Products | 2022-12-08 |
| 30609576900069 | Puritan UniTranz-RT | Puritan Medical Products | 2022-12-08 |
| 30609576900076 | Puritan UniTranz-RT | Puritan Medical Products | 2022-12-08 |
| 30609576900083 | Puritan UniTranz-RT | Puritan Medical Products | 2022-12-08 |
| 30609576900090 | Puritan UniTranz-RT | Puritan Medical Products | 2022-12-08 |
| 30609576900106 | Puritan UniTranz-RT | Puritan Medical Products | 2022-12-08 |
| 18053326003742 | LBM® UriSponge™ | COPAN ITALIA SPA | 2022-12-07 |
| 28053326000250 | FecalSwab™ | COPAN ITALIA SPA | 2022-12-07 |
| 28053326000304 | FecalSwab™ | COPAN ITALIA SPA | 2022-12-07 |
| 18053326003735 | LBM® UriSponge™ | COPAN ITALIA SPA | 2022-12-07 |
| 18053326003728 | LBM® UriSponge™ | COPAN ITALIA SPA | 2022-12-07 |
| 18053326003711 | LBM® UriSponge™ | COPAN ITALIA SPA | 2022-12-07 |
| 25420045514765 | Rapid fFN | Hologic, Inc. | 2022-11-15 |
| 10885380163531 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2018-12-18 |
| 10885380163562 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2018-12-18 |
| 10885380163555 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2018-12-18 |
| 10885380163548 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2018-12-18 |
| 19120049206732 | VACUETTE | Greiner Bio-One GmbH | 2017-05-18 |
| 19120049206725 | VACUETTE | Greiner Bio-One GmbH | 2017-05-18 |
| 29120049200348 | VACUETTE | Greiner Bio-One GmbH | 2017-04-27 |
| 29120049200317 | VACUETTE | Greiner Bio-One GmbH | 2017-04-27 |
| 29120049200300 | VACUETTE | Greiner Bio-One GmbH | 2017-04-27 |
| 29120017577328 | VACUETTE | Greiner Bio-One GmbH | 2017-04-06 |