Device product

NEL- GBS Medium (Broth 3 ml Fill 13 x 100 mm Screw Cap Tube Catalog No.: T8000; For the selective enrichment and screening of Beta-Hemolytic Streptococcus agalactiae (Group B Strep).

Z-1314-2016

December 21, 2015

Class II

Product summary

Firm: Northeast Laboratory Services, Inc.
Event: Event 73325
Status: Terminated
Classification: Class II
Quantity: 11720
Official record key: device-enforcement:Z-1314-2016

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)