Device, Specimen Collection
FDA product code LIO · Class I (low risk) · 21 CFR 866.2900 · Microbiology
63510(k) clearances
0PMA approvals
3recalls
Manufacturers
- Remel Co. 5
- Pro-Lab Diagnostics 4
- Medical Laboratory Automation Systems, Inc. 3
- Sage Products, Inc. 3
- Ncs Diagnostics, Inc. 2
- Medical Packaging Corp. 2
- Para Scientific Co. 2
- Bio-Rad 2
- Kallestad Diag, A Div. of Erbamont, Inc. 2
- Puritan Medical Products, LLC 2
- Preventive Diagnostics Corp. 2
- Syva Co. 2
- Medical Wire & Equipment Company (Bath), Ltd. 2
- Xsirius Scientific, Inc. 1
- Intl. Research Distributors, Inc. 1
- Boots-Celltech Diagnostics, Inc. 1
- Analytical Luminescence Laboratory, Inc. 1
- M.G. Laboratories, Inc. 1
- Concord Laboratories, Inc. 1
- Molecular Biosystems, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K222613 | ARX Liquid Amies Collection & Transport SystemLIO · Traditional | Arx Sciences, Inc. | 03/27/2024SE |
| K131630 | Puritan Amies Medium Collection and Transport SystemLIO · Traditional | Puritan Medical Products, LLC | 10/21/2013SE |
| K120846 | Transport Culture Medium DeviceLIO · Traditional | Puritan Medical Products, LLC | 06/08/2012SE |
| K103805 | Medical Wire & Equipment S-Transwab (or Sigma-Transwab) Liquid Amies Collection and…LIO · Special | Medical Wire & Equipment Company (Bath), Ltd. | 01/25/2011SE |
| K082472 | Virocult, Model MW950LIO · Abbreviated | Medical Wire & Equipment Company (Bath), Ltd. | 12/30/2008SE |
| K070062 | Coproset Salmonella and Shigella, Uriset Preservative Tubes and Swab Set General UseLIO · Traditional | Diesse Diagnostica Senese S.P.A. | 07/30/2007SE |
| K013711 | Bacti-Swab DryLIO · Traditional | Remel Co. | 11/26/2001SE |
| K003761 | Nat - Nucleic Acid TransportLIO · Traditional | Medical Packaging Corp. | 05/31/2001SE |
| K983119 | Entero-Test HP, Model #102-01LIO · Traditional | Hdc Corp. | 03/15/1999SE |
| K981391 | Par-OneLIO · Traditional | Remel, Inc. | 07/14/1998SE |
| K964144 | Paracon Plus Formalin - Pcp-F, Paracon Plus Saf - Pcp-Saf and Paracon Plus MF - Pcp-MfLIO · Traditional | Para Scientific Co. | 11/27/1996SE |
| K963986 | STP System Pva with ZincLIO · Traditional | Sage Products, Inc. | 11/08/1996SE |
| K964026 | STP System - SafLIO · Traditional | Sage Products, Inc. | 11/07/1996SE |
| K964027 | STP System-Pva with MercuryLIO · Traditional | Sage Products, Inc. | 11/01/1996SE |
| K960997 | Starswab Culture Collection and Transport SystemLIO · Traditional | Starplex Scientific, Inc. | 04/03/1996SE |
| K953929 | Mid-Stream Collection Set-SterileLIO · Traditional | Trinity Laboratories, Inc. | 11/16/1995SE |
| K950096 | Pinworm Egg CollectorLIO · Traditional | Evergreen Industries, Inc. | 04/05/1995SE |
| K931770 | Para-Pak PlusLIO · Traditional | Meridian Diagnostics, Inc. | 06/15/1993SE |
| K931383 | Zinc PvaLIO · Traditional | Remel Co. | 06/15/1993SE |
| K930313 | Apex Specimen BagLIO · Traditional | Apex Medical Technologies, Inc. | 03/18/1993SE |
| K924053 | Cytoquant Combined Transport MediaLIO · Traditional | Proteins Intl., Inc. | 01/15/1993SE |
| K924331 | Transystem Liquid Stuart MediumLIO · Traditional | Pro-Lab Diagnostics | 12/24/1992SE |
| K924330 | Transystem Amies with CharcoalLIO · Traditional | Pro-Lab Diagnostics | 12/24/1992SE |
| K924329 | Transystem Amies W/O CharcoalLIO · Traditional | Pro-Lab Diagnostics | 12/24/1992SE |
| K924328 | Transystem Liquid Amies MediumLIO · Traditional | Pro-Lab Diagnostics | 12/24/1992SE |
| K920536 | Affirm VP Sample Collection SetLIO · Traditional | Microprobe Corp. | 07/30/1992SE |
| K920761 | Urine Cultur Stabilization Transport TubeLIO · Traditional | Bio Medicus, Inc. | 06/19/1992SE |
| K915454 | Chlamydia Trachomatis Specimen Collection KitLIO · Traditional | Medical Packaging Corp. | 04/08/1992SE |
| K912832 | Bacti-Swab(Tm) NPGLIO · Traditional | Remel Co. | 08/22/1991SE |
| K912831 | Bacti-Swab(Tm) IILIO · Traditional | Remel Co. | 07/30/1991SE |
| K903638 | Gastro-Intestinal Accu-Culshure TMLIO · Traditional | Medical Laboratory Automation Systems, Inc. | 01/18/1991SE |
| K905120 | Saf FixativeLIO · Traditional | Gibson Laboratories, Inc. | 12/17/1990SE |
| K903406 | Viral Accu-Culshure TMLIO · Traditional | Medical Laboratory Automation Systems, Inc. | 10/16/1990SE |
| K903405 | Chlamydia Accu-Culshure TMLIO · Traditional | Medical Laboratory Automation Systems, Inc. | 10/16/1990SE |
| K902467 | Flora-Stat Urine Transport SystemLIO · Traditional | Wadley Biosciences Corp. | 08/22/1990SE |
| K896794 | Specimen ContainerLIO · Traditional | Westmark, Sterile Packing Systems, Inc. (Sps) | 03/01/1990SE |
| K900225 | Romcheck Specimen Collection KitLIO · Traditional | Adeza Biomedical | 02/02/1990SE |
| K893905 | Pathodx(Tm) Chlamydia Direct Specimen (PDCY1)LIO · Traditional | Diagnostic Products Corp. | 08/03/1989SE |
| K890134 | FTK Fecal Transport KitLIO · Traditional | Evergreen Scientific, Inc. | 04/21/1989SE |
| K884342 | Novapath Specimen Collection KitLIO · Traditional | Bio-Rad | 11/03/1988SE |
| K882485 | Diversi-KitLIO · Traditional | Intl. Cancer Screening Laboratories, Inc. | 07/18/1988SE |
| K873565 | Snap(R) Rotavirus Diagnostic KitLIO · Traditional | Molecular Biosystems, Inc. | 05/13/1988SE |
| K881125 | Pathfinder(Tm) Chlamydia Eia Brush Collection KitLIO · Traditional | Kallestad Diag, A Div. of Erbamont, Inc. | 03/23/1988SE |
| K874456 | Chlamydia Stat Direct Smear Collection KitLIO · Traditional | Tm & M C/O Burditt,Bowles,Radzius & Ruberry, Ltd. | 11/24/1987SE |
| K872751 | Fluortran - C(Tm)LIO · Traditional | Para Scientific Co. | 07/23/1987SE |
| K871860 | Novapath C. Trachomatis Direct Spec Collection KitLIO · Traditional | Bio-Rad | 05/29/1987SE |
| K870963 | Modified Pathfinder Specimen Collection KitLIO · Traditional | Kallestad Diag, A Div. of Erbamont, Inc. | 04/08/1987SE |
| K870231 | KultsureLIO · Traditional | Ncs Diagnostics, Inc. | 02/04/1987SE |
| K864727 | Cult-UrLIO · Traditional | R.P. Laboratories, Inc. | 01/05/1987SE |
| K862607 | Imagen(Tm) Chlamydia Specimen Collection KitLIO · Traditional | Boots-Celltech Diagnostics, Inc. | 08/04/1986SE |
| K860655 | Kultsure (Catalogue No. M200)LIO · Traditional | Ncs Diagnostics, Inc. | 03/06/1986SE |
| K854719 | Lung Care (Specimen Transport & Storage Container)LIO · Traditional | Xsirius Scientific, Inc. | 02/24/1986SE |
| K851378 | Virtran Viral TranporterLIO · Traditional | Diagnon Corp. | 06/21/1985SE |
| K851387 | Microstatic Urine Transport Tube for C & SLIO · Traditional | Analytical Luminescence Laboratory, Inc. | 05/20/1985SE |
| K843000 | Micro Organism Growth SYS-M1000LIO · Traditional | Hml Inc/Biotechnology Transfer | 02/06/1985SE |
| K843935 | Modification Microtrak Direct Specimen TestLIO · Traditional | Syva Co. | 10/23/1984SE |
| K840799 | V.D.T.-Gonorrhea Test KitLIO · Traditional | M.G. Laboratories, Inc. | 06/07/1984SE |
| K833814 | Sani Catch BaLIO · Traditional | Concord Laboratories, Inc. | 03/19/1984SE |
| K834566 | Preserv Saf Fixative 15MLLIO · Traditional | Preventive Diagnostics Corp. | 02/04/1984SE |
| K840086 | Preserv MF Fixative 15MLLIO · Traditional | Preventive Diagnostics Corp. | 01/30/1984SE |
| K832079 | Collection Kit Chlamydia TrachomatisLIO · Traditional | Syva Co. | 09/29/1983SE |
| K832246 | Dupont Isolator 1.5 Microbial TubeLIO · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 09/26/1983SE |
| K820520 | VD AlertLIO · Traditional | Intl. Research Distributors, Inc. | 05/14/1982SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1095-2025 Class II | The Rapid fFN Specimen Collection Tube (PN: 71550-001) is a component of the Rapid fFN…Three lots of Rapid fFN Specimen Collection kit (901164, 901165, and 904850) contain Rapid fFN Specimen… | Hologic, Inc. | 01/08/2025Open, Classified |
| Z-0449-2021 Class II | Wuxi Nest, model numbers 202115, 202117, 202017, 202018 - Product Usage: Patient…The firm is replacing all tubes that were manufactured and distributed prior to Enforcement Discretion… | Thomas Scientific | 07/14/2020Open, Classified |
| Z-1812-2009 | Remel BactiSwab NPG Collection and Transport System, Sterile, 100 swab units/box…Incorrect expiration date on the product | Remel, Inc | 05/07/2009Terminated |