Urine Collection Kit (Excludes Hiv Testing)
Regulation 864.3250
0510(k)s in 12 months (0 all time)
1recalls in 12 months (2 all time)
1recalls that name a 510(k)
Top companies in OIE
| Company | 510(k)s | Recalls |
|---|---|---|
| Gen-Probe Inc | 0 | 1 |
| Medical Action Industries, Inc. 306 | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 2, 2026 | Medical Action Industries, Inc. 306 Generic Name: Kit, Urine, Clean Catch
Trade Name: Kit: Urinary Clean Catch 20/cs
Model/Catalog Number: 76769
Lot Number: 333606
UDI-DI: 20809160118228
Software Version: N/A Open, Classified |
OIE | None listed |
| Jun 14, 2014 | Gen-Probe Inc APTIMA Urine Collection Kit; Catalog Number
301040, Lots 27231, 27232, 27233, and 27234.
Product Usage: The APTIMA Urine Specimen Collection Kit for Male and Female Urine Specimens is for use with A Terminated |
OIE | K003395 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.