Device product

NEL GBS Medium 20 ml in 100x15mm plate (Standard Petri Dish) Catalog No.: P8000; For the selective enrichment and screening of Beta-Hemolytic Streptococcus agalactiae (Group B Strep).

Z-1313-2016

December 21, 2015

Class II

Product summary

Firm: Northeast Laboratory Services, Inc.
Event: Event 73325
Status: Terminated
Classification: Class II
Quantity: 9300
Official record key: device-enforcement:Z-1313-2016

Official wording

Reason: Product marketed without a 510 (k)

Code information: Al lot codes

Distribution pattern: Nationwide Distribution.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Product marketed without a 510 (k)