MINI S.F.T. (URINE PRESERVATIVE)

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

MAGNET PAD

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

PLATELET CONCENTRATE SEPARATION KIT FOR CELSEP CENTRIFUGE SYSTEM

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

Lab-Based Hiv Nat Diagnostic And/Or Supplemental Test

FDA classification

FDA Class 2 ·Lab-Based Hiv Nat Diagnostic And/Or Supplemental Test

Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings

FDA classification

FDA Class 2 ·Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings

Monitor,Test,Hiv-1

FDA classification

FDA Class 3 ·Monitor,Test,Hiv-1

Test, Factor Ii G20210a Mutations, Genomic Dna Pcr

FDA classification

FDA Class 2 ·Test, Factor Ii G20210a Mutations, Genomic Dna Pcr

Test, Factor V Leiden Mutations, Genomic Dna Pcr

FDA classification

FDA Class 2 ·Test, Factor V Leiden Mutations, Genomic Dna Pcr

Nucleic Acid Amplification Test For The Quantitation Of Bk Virus (Bk) Dna

FDA classification

FDA Class 2 ·Nucleic Acid Amplification Test For The Quantitation Of Bk Virus (Bk) Dna

Dengue Nucleic Acid Amplification Assay (Naat)

FDA classification

FDA Class 2 ·Dengue Nucleic Acid Amplification Assay (Naat)

Processor, Cervical Cytology Slide, Automated

FDA classification

FDA Class 3 ·Processor, Cervical Cytology Slide, Automated

Reagents, Monkeypox Virus Nucleic Acid.

FDA classification

FDA Not Classified ·Reagents, Monkeypox Virus Nucleic Acid.

Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna

FDA classification

FDA Class 2 ·Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna

Zika Virus Serological Reagents

FDA classification

FDA Class 2 ·Zika Virus Serological Reagents

Hepatitis Viral B Dna Detection

FDA classification

FDA Class 3 ·Hepatitis Viral B Dna Detection

Herpes Simplex Virus Nucleic Acid Amplification Assay

FDA classification

FDA Class 2 ·Herpes Simplex Virus Nucleic Acid Amplification Assay

Elisa, Antibody, West Nile Virus

FDA classification

FDA Class 2 ·Elisa, Antibody, West Nile Virus

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA classification

FDA Class 2 ·Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA classification

FDA Class 2 ·Cytomegalovirus (Cmv) Dna Quantitative Assay

Somatic Gene Mutation Detection System

FDA classification

FDA Class 3 ·Somatic Gene Mutation Detection System