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The NATtrol™ Group B Streptococcus (GBS) Negative Control is an unassayed in vitro diagnostic external run control intended to be used with qualitative molecular assays for detection of nucleic acids from this organism. The control is intended to be used as an aid to diagnosis in that it is used to verify performance of the assays used to detect a physiological or pathological state. The routine and repetitive use of external run controls enables laboratories to monitor daily test variation, lot-to-lot test kit performance, individual operator variation, and can provide assistance in identifying increases in random or systemic errors. NATtrol™ GBS Negative Control contains intact organisms and should be run in a manner identical to that used for clinical specimens. The control does not have an assigned value and it is the responsibility of the end user to establish their own target specifications for the control using their laboratory’s molecular procedures.
ZEPTOMETRIX CORPORATION
NATtrol™ Group B Streptococci Negative Control
In Commercial Distribution
- 01220000260153 ()
NATLAC-6MC-IVD
- Beta-haemolytic Group B Streptococcus nucleic acid IVD, control
The NATtrol™ Group B Streptococcus (GBS) Positive Control is an unassayed in vitro diagnostic external run control intended to be used with qualitative molecular assays for detection of nucleic acids from this organism. The control is intended to be used as an aid to diagnosis in that it is used to verify performance of the assays used to detect a physiological or pathological state. The routine and repetitive use of external run controls enables laboratories to monitor daily test variation, lot-to-lot test kit performance, individual operator variation, and can provide assistance in identifying increases in random or systemic errors. NATtrol™ GBS Positive Control contains intact organisms and should be run in a manner identical to that used for clinical specimens. The control does not have an assigned value and it is the responsibility of the end user to establish their own target specifications for the control using their laboratory’s molecular procedures.
ZEPTOMETRIX CORPORATION
NATtrol™ Group B Streptococci Positive Control
In Commercial Distribution
- 01220000260146 ()
NATSAG-6MC-IVD
- Beta-haemolytic Group B Streptococcus nucleic acid IVD, control
Group B Strep Positive
MICROBIOLOGICS INC.
GBS-01
In Commercial Distribution
- 10634853001265 ()
GBS-01
- Beta-haemolytic Group B Streptococcus nucleic acid IVD, control
No Description
DIASORIN SPA
318223
In Commercial Distribution
- 08056771103466 ()
- Hepatitis B virus surface total antibody IVD, control
No Description
DIASORIN SPA
318221
In Commercial Distribution
- 08056771103459 ()
- Hepatitis B virus surface total antibody IVD, control
No Description
DIASORIN SPA
318161
In Commercial Distribution
- 28056771103439 ()
- 08056771103435 ()
- Hepatitis B virus e-antigen total antibody IVD, control
GBS Positive Run Control
EXACT DIAGNOSTICS, LLC
12020069
In Commercial Distribution
- 03610522384389 ()
12020069
- Beta-haemolytic Group B Streptococcus nucleic acid IVD, control
The illumigene GBS External Control Kit contains Positive and Negative Control Reagents for use with the illumigene Group B Streptococcus test kit. External controls are used as part of a routine quality control program.
MERIDIAN BIOSCIENCE, INC.
279900
Not in Commercial Distribution
- 00840733101311 ()
279900
- Beta-haemolytic Group B Streptococcus nucleic acid IVD, control
The Alethia GBS External Control Kit contains Positive and Negative Control Reagents for use with the Alethia Group B Streptococcus test kit. External controls are used as part of a routine quality control program.
MERIDIAN BIOSCIENCE, INC.
479900
In Commercial Distribution
- 00840733102110 ()
479900
- Beta-haemolytic Group B Streptococcus nucleic acid IVD, control
Anti-HBe2 (aHBe2) – ADVIA Centaur – QC Kit
Siemens Healthcare Diagnostics Inc.
10720832
In Commercial Distribution
- 00630414167947 ()
10720832
- Hepatitis B virus e-antigen total antibody IVD, control