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NC Department of Health and Human Services
State Laboratory of Public Health
 N.C. Public Health Home
 
 

Medical Device Information

In accordance with the U.S Food and Drug Administration (FDA) final rule regarding Laboratory Developed Tests (LDTs), the North Carolina State Laboratory of Public Health is implementing this medical device form to collect information regarding medical device performance and adverse events. As defined, a medical device is an in vitro diagnostic product, in this case an LDT, used, designed, or manufactured in a single, certified CLIA laboratory for clinical use. An adverse event is a serious injury or illness that is life threatening, results in permanent impairment or damage to a body function or structure or requires medical intervention to prevent the permanent impairment or damage to a body function or structure.

If your facility submits specimens to the North Carolina State Laboratory of Public Health (NCSLPH) for any of the tests below, and have encountered a problem with

  • the results of the test,
  • the quality of testing/products used for testing, or
  • an adverse event has occurred

please use the Medical Device Reporting form to report the issue, immediately upon discovery. 

NCSLPH LDT list:

4-hydroxy-3-nitrophenylacetic acid (HNPAA) 

Measles RT-PCR 

Abrine/Ricinine 

Mercury in Urine 

Antimicrobial Susceptibility Testing for Mycobacterium tuberculosis complex 

Mycobacterium tuberculosis complex/Mycobacterium avium-intracellulare complex (TBMAC) PCR 

Blood Lead by ICP-MS 

Organophosphate nerve agents (OPNA) Serum 

Blood Metals 

Organophosphate nerve agents (OPNA) Urine 

Bordetella pertussis PCR 

Orthopoxvirus RT-PCR 

Brucella RT-PCR 

Severe Combined Immunodeficiency (SCID)/ Spinal Muscular Atrophy (SMA) 

Burkholderia RT-PCR 

Tetramine 

Carbapenem Resistant Enterobacterales (CRE) mCIM (Clinical and Surveillance) 

Tuberculosis B Resistance surveillance/retrospective 

Carbapenem Resistant Enterobacterales (CRE) real-time PCR (Clinical and Surveillance) 

Urine Metals 

Chikungunya IgM ELISA 

Varicella-Zoster Virus (VZV) RT-PCR 

Coxiella and DNA Blood mini kit extraction 

Volatile Organic Compounds 

Cyanide 

Whole Genome Sequencing (WGS) for Listeria Monocytogenes (Surveillance only) 

Cystic Fibrosis Transmembrane Conductance Regular (CFTR) DNA 

Whole Genome Sequencing (WGS) for Salmonella serotyping (Clinical and Surveillance) 

Francisella tularensis DFA 

Whole Genome Sequencing (WGS) for Shigella (Surveillance only) 

Francisella tularensis RT-PCR 

Whole Genome Sequencing (WGS) for STEC (Surveillance only) 

Galactosemia amplification refractory mutation system polymerase chain reaction (GALT ARMS) PCR 

Whole Genome Sequencing for Campylobacter (Surveillance only) 

HMAS for Salmonella (CDC pilot study) 

X-linked Adrenoleukodystrophy (ALD)- R (Relex Testing) (ALD-R) 

Known Phenylketonuria (PKU) 

Yersinia pestis RT-PCR 

LaCrosse IgM ELISA 

 

Once submission is complete, the laboratory will contact you for further information if necessary.


 

NCDHHS

Updated: February 25, 2025