Molecular Diagnostic Control Panel Helix Elite™ Group B Strep (GBS) Positive Level / Negative Level 12 Swabs

Name: Control Panel
Brand: Helix Elite™

PANEL, CONTROL RAPID GROUP B STREPTOCOCCUS GBS (12/EA) D/S

McKesson #

1227723

Manufacturer #

8242

Brand

Helix Elite™

Manufacturer

Microbiologics Inc

Country of Origin

United States

Application

Control Panel

Buy American Act (BAA) Compliant

For Use With

For Evaluating the Performance of Nucleic Acid Amplification Testing (NAAT) Procedures that Detect Group B Streptococcus

Form

Lyophilized

Levels

Positive Level / Negative Level

Product Dating

McKesson Acceptable Dating: we will ship >= 30 days

Test Category

Other Infectious Disease

Test Name

Group B Strep (GBS)

Test Type

Molecular Diagnostic

Trade Agreement Act (TAA) Compliant

Yes

UNSPSC Code

41116131

Volume

12 Swabs

The Rapid Group B Streptococcus (GBS) Control Panel contains six inactivated pre-pooled positive control swabs, and six inactivated negative control swabs (12 swabs total)
Rapid Group B Streptococcus (GBS) Control Panel is intended for use as non-viable, external, positive, and negative control materials to evaluate the performance of nucleic acid amplification testing (NAAT) procedures that detect Group B Streptococcus (GBS, Streptococcus agalactiae) in direct specimens
Nonautomated and intended to be used for screening, monitoring, or diagnosis
Positive Control (six swabs): Group B Streptococcus (Streptococcus agalactiae)
Negative Control (six swabs): Lactobacillus acidophilus Escherichia coli surrogate for sample adequacy control