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Conditionally Approved

A2Z Diagnostics, LLC

Project ID: 
85821
Facility ID: 
9370
Facility Name: 
A2Z Diagnostics, LLC
Facility State: 
NJ
Analyte: 
COVID-19 nucleic acid iAMP COVID-19 detection kit (ATILA Biosystems)
Analyte Synonym: 
Includes SARS-CoV-2 for COVID-19
Method: 
RT-PCR
Specimen Type: 
saliva: supervised collection
Permit Category: 
Virology
Status: 
Conditionally Approved

Access DX Laboratory, LLC

Project ID: 
85820
Facility ID: 
8808
Facility Name: 
Access DX Laboratory, LLC
Facility State: 
TX
Analyte: 
COVID-19 Multiplex RT-PCR (Applied Biosystems ViiA 7 Real-Time PCR system, Quant Studio 12K Flex Real-Time PCR System-384 block)
Analyte Synonym: 
Includes SARS-CoV-2 for COVID-19
Method: 
RT-PCR
Specimen Type: 
respiratory: NP, NS
Permit Category: 
Virology
Status: 
Conditionally Approved

Access DX Laboratory, LLC

Project ID: 
55074
Facility ID: 
8808
Facility Name: 
Access DX Laboratory, LLC
Facility State: 
TX
Analyte: 
pharmacogenetic drug sensitivity testing (new marker additions for DNA Drug Sensitivity & Oncology Drug Sensitivity)
Method: 
PCR/SNP genotyping/fragment analysis/Sanger Sequencing
Specimen Type: 
saliva; whole blood
Permit Category: 
Genetic Testing - Molecular
Status: 
Conditionally Approved

Access Genetics LLC - Clinical Laboratory

Project ID: 
39071
Facility ID: 
8488
Facility Name: 
Access Genetics LLC - Clinical Laboratory
Facility State: 
MN
Analyte: 
MyPerioID (IL-6 gene polymorphisms, IL-6GX)
Analyte Synonym: 
Interleukin 6 gene polymorphism
Method: 
PCR/RFLP with automated fluorescent microcapillary chip electrophoresis detection
Specimen Type: 
saliva: oral rinse
Permit Category: 
Genetic Testing - Molecular
Status: 
Conditionally Approved

Accu Reference Medical Lab LLC

Project ID: 
93219
Facility ID: 
8205
Facility Name: 
Accu Reference Medical Lab LLC
Facility State: 
NJ
Analyte: 
serotonin
Method: 
HPLC
Specimen Type: 
serum
Permit Category: 
Endocrinology
Status: 
Conditionally Approved

Accu Reference Medical Lab LLC

Project ID: 
85081
Facility ID: 
8205
Facility Name: 
Accu Reference Medical Lab LLC
Facility State: 
NJ
Analyte: 
vitamin B6 (pyridoxal-5-phosphate)
Method: 
HPLC
Specimen Type: 
plasma: heparinized
Permit Category: 
Endocrinology
Status: 
Conditionally Approved

Accu Reference Medical Lab LLC

Project ID: 
93239
Facility ID: 
8205
Facility Name: 
Accu Reference Medical Lab LLC
Facility State: 
NJ
Analyte: 
antibiotic resistance gene panel
Method: 
real-time PCR
Specimen Type: 
urine; wound: Eswabs
Permit Category: 
Bacteriology
Status: 
Conditionally Approved

Accu Reference Medical Lab LLC

Project ID: 
93344
Facility ID: 
8205
Facility Name: 
Accu Reference Medical Lab LLC
Facility State: 
NJ
Analyte: 
methylmalonic acid
Method: 
LC-MS/MS
Specimen Type: 
plasma: heparinized; serum
Permit Category: 
Endocrinology
Status: 
Conditionally Approved

Accu Reference Medical Lab LLC

Project ID: 
88379
Facility ID: 
8205
Facility Name: 
Accu Reference Medical Lab LLC
Facility State: 
NJ
Analyte: 
fat soluble vitamins
Method: 
HPLC
Specimen Type: 
plasma: heparinized
Permit Category: 
Endocrinology
Status: 
Conditionally Approved

Accu Reference Medical Lab LLC

Project ID: 
94162
Facility ID: 
8205
Facility Name: 
Accu Reference Medical Lab LLC
Facility State: 
NJ
Analyte: 
free testosterone
Method: 
LC-MS/MS
Specimen Type: 
serum
Permit Category: 
Endocrinology
Status: 
Conditionally Approved

Accu Reference Medical Lab LLC

Project ID: 
94180
Facility ID: 
8205
Facility Name: 
Accu Reference Medical Lab LLC
Facility State: 
NJ
Analyte: 
free cortisol
Method: 
LC-MS/MS
Specimen Type: 
serum
Permit Category: 
Endocrinology
Status: 
Conditionally Approved

Accu Reference Medical Lab LLC

Project ID: 
86319
Facility ID: 
8205
Facility Name: 
Accu Reference Medical Lab LLC
Facility State: 
NJ
Analyte: 
vitamin C
Method: 
HPLC
Specimen Type: 
plasma: heparinized
Permit Category: 
Endocrinology
Status: 
Conditionally Approved

Accu Reference Medical Lab LLC

Project ID: 
90520
Facility ID: 
8205
Facility Name: 
Accu Reference Medical Lab LLC
Facility State: 
NJ
Analyte: 
25-OH vitamin D2/D3
Method: 
LC/MS
Specimen Type: 
plasma: heparinized; serum
Permit Category: 
Endocrinology
Status: 
Conditionally Approved

Accupath Diagnostic Laboratories Inc

Project ID: 
35069
Facility ID: 
8793
Facility Name: 
Accupath Diagnostic Laboratories Inc
Facility State: 
AZ
Analyte: 
DLEU (13q14)-SV replacement in CLL1 probe mix)
Method: 
FISH
Specimen Type: 
bone marrow: interphase/metaphase; peripheral blood: interphase/metaphase
Permit Category: 
Cytogenetics
Status: 
Conditionally Approved

Accupath Diagnostic Laboratories Inc

Project ID: 
92420
Facility ID: 
8793
Facility Name: 
Accupath Diagnostic Laboratories Inc
Facility State: 
AZ
Analyte: 
ALK (2p23)
Method: 
FISH
Specimen Type: 
tissue: FFPE interphase nuclei
Permit Category: 
Cytogenetics
Status: 
Conditionally Approved

Accupath Diagnostic Laboratories Inc

Project ID: 
52877
Facility ID: 
8302
Facility Name: 
Accupath Diagnostic Laboratories Inc
Facility State: 
TN
Analyte: 
Pediatric ALL FISH Panel
Method: 
FISH
Specimen Type: 
bone marrow: interphase; peripheral blood: interphase
Permit Category: 
Cytogenetics
Status: 
Conditionally Approved

Accupath Diagnostic Laboratories Inc

Project ID: 
50334
Facility ID: 
8793
Facility Name: 
Accupath Diagnostic Laboratories Inc
Facility State: 
AZ
Analyte: 
ALK break apart (modification)
Method: 
FISH
Specimen Type: 
tissue: FFPE lung interphase
Permit Category: 
Cytogenetics
Status: 
Conditionally Approved

Accupath Diagnostic Laboratories Inc

Project ID: 
52878
Facility ID: 
8302
Facility Name: 
Accupath Diagnostic Laboratories Inc
Facility State: 
TN
Analyte: 
Aggressive B-Cell Lymphoma FISH Panel
Method: 
FISH
Specimen Type: 
tissue: FFPE; peripheral blood: interphase; bone marrow: interphase
Permit Category: 
Cytogenetics
Status: 
Conditionally Approved

Accupath Diagnostic Laboratories Inc

Project ID: 
35089
Facility ID: 
8793
Facility Name: 
Accupath Diagnostic Laboratories Inc
Facility State: 
AZ
Analyte: 
CDKN2A-CEP9
Method: 
FISH
Specimen Type: 
peripheral blood: interphase/metaphase; bone marrow: interphase/metaphase
Permit Category: 
Cytogenetics
Status: 
Conditionally Approved

Accupath Diagnostic Laboratories Inc

Project ID: 
35470
Facility ID: 
8793
Facility Name: 
Accupath Diagnostic Laboratories Inc
Facility State: 
AZ
Analyte: 
FIP1L1 (4q12), CHIC2 (4q12), PDGFRA (4q12)
Method: 
FISH
Specimen Type: 
bone marrow: interphase/metaphase; peripheral blood: interphase/metaphase
Permit Category: 
Cytogenetics
Status: 
Conditionally Approved
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