Bacteriology Medical Devices Page: 21

IVD RESEARCH C.DIFFICILE TOXIN A+B FECAL ANTIGEN DETECTION MICROWELL ELISA
Clostridium difficile |
HIGH
JANT Accutest Rapid Urease test
Helicobacter pylori |
CLIA WAIVED
Jant Pharmacal AccuStrip Strep A (II)
Streptococcus, group A |
CLIA WAIVED
Jant Pharmacal Accustrip Strep A Value+ Test Strip
Streptococcus, group A |
CLIA WAIVED
Jant Pharmacal Accutest Integrated Strep A Rapid Test Device
Streptococcus, group A |
CLIA WAIVED
JANT PHARMACAL CORP CLINIPAK STREP A RAPID TEST STRIP
Streptococcus, group A |
CLIA WAIVED
Jant Pharmacal Corporation Accutest Uriscreen
Catalase, urine |
CLIA WAIVED
Johnson & Johnson CDI SureCell
Chlamydia | Herpes simplex | Streptococcus, group A |
View Complexity
Karobio Phadebact CSF
Haemophilus influenzae, type b | Neisseria meningitidis, group A | Neisseria meningitidis, group B | Neisseria meningitidis, group C | Neisseria meningitidis, group W135 | Neisseria meningitidis, group Y | Streptococcus pneumoniae | Streptococcus, group B |
View Complexity
Karobio Phadebact Haemophilus
Haemophilus influenzae, type a, c-f | Haemophilus influenzae, type b |
View Complexity
Karobio Phadebact Monoclonal Gonococcus
Neisseria gonorrhoeae |
HIGH
Karobio Phadebact Pneumococcus
Streptococcus pneumoniae |
HIGH
Karobio Phadebact Streptococcus
Streptococcus, group A | Streptococcus, group B | Streptococcus, group C | Streptococcus, group D | Streptococcus, group F | Streptococcus, group G |
View Complexity
Karobio Phadirect Strep A Test
Streptococcus, group A |
MODERATE
KeyPath MRSA/MSSA Blood Culture Test – BT
Staphylococcus |
HIGH
Kodak SureCell
Streptococcus, group A |
MODERATE
LABORATORY SUPPLY COMPANY (LSC) PEP STREP A CASSETTE TEST
Streptococcus, group A |
CLIA WAIVED
LABORATORY SUPPLY COMPANY (LSC) PEP STREP A DIPSTICK TEST
Streptococcus, group A |
CLIA WAIVED
LABSCO ADVANTAGE Strep A
Streptococcus, group A |
CLIA WAIVED
Laison Treponemal Assay
Treponema pallidum |
MODERATE
Laison Treponemal Assay (Laison Analyzer) (Automated)
Treponema pallidum |
MODERATE
Leeco Diagnostics Preview Strep A
Streptococcus, group A |
MODERATE
LIFESIGN LLC STATUS STREP A
Streptococcus, group A |
CLIA WAIVED
LifeSign Status AccuStrep A
Streptococcus, group A |
MODERATE
LifeSign Streptolex STAT
Streptococcus, group A | Streptococcus, group B | Streptococcus, group C | Streptococcus, group F | Streptococcus, group G |
View Complexity


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