FDA Registration
Active
🇺🇸 United States
INOVA DIAGNOSTICS, INC.
Reg #: 2026994
·
FEI: 2026994
·
Expires 2026
Products
45
Proprietary Names
374
Establishment Types
5
Classifications
45
Registration Details
- Registration Name
- INOVA DIAGNOSTICS, INC.
- Registration Number
- 2026994
- FEI Number
- 2026994
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 9900 Old Grove Rd
- City
- SAN DIEGO
- State
- CA
- ZIP
- 92131
- Country
- US
Regulatory Submissions
- 510(k) Number
- K061841
Owner / Operator
- Firm Name
- INOVA DIAGNOSTICS, INC.
- Operator Number
- 2026994
- Address
- 9900 OLD GROVE RD., --
- City
- San Diego
- State
- CA
- Postal Code
- 92131
- Country
- US
- Correspondent
- Constance Bridges
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Radioassay, Intrinsic Factor Blocking Antibody | LIG | Class 2 | Clinical Chemistry | No | 2007-01-22 |
| Extractable Antinuclear Antibody, Antigen And Control | LLL | Class 2 | Immunology | No | 2012-08-02 |
| General Purpose Reagent | PPM | Class 1 | Pathology | No | 2018-01-30 |
| Enzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control | MLE | Class 2 | Immunology | No | 2009-01-14 |
| Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1) | NBS | Class 2 | Immunology | No | 2009-01-14 |
| System, Test, Anticardiolipin Immunological | MID | Class 2 | Immunology | No | 2026-06-09 |
| System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) | MSV | Class 2 | Immunology | No | 2026-06-09 |
| Multi-Analyte Controls Unassayed | OHQ | Class 1 | Clinical Chemistry | No | 2013-09-12 |
| Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control | LRM | Class 2 | Immunology | No | 2012-08-09 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2013-05-16 |
| Calibrator, Multi-Analyte Mixture | JIX | Class 2 | Clinical Chemistry | No | 2013-05-16 |
| Anti-Ss-A 52 Autoantibodies | OBE | Class 2 | Immunology | No | 2007-04-18 |
| Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody | NYO | Class 2 | Immunology | No | 2007-05-02 |
| Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use | PIV | Class 2 | Immunology | No | 2015-12-02 |
| Calibrator, Secondary | JIT | Class 2 | Clinical Chemistry | No | 2015-02-17 |
| Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | DHN | Class 2 | Immunology | No | 2009-01-26 |
| Antibodies, Gliadin | MST | Class 2 | Immunology | No | 2012-08-09 |
| Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | MOB | Class 2 | Immunology | No | 2012-08-02 |
| Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm) | MVJ | Class 2 | Immunology | No | 2012-08-02 |
| Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control | DBL | Class 2 | Immunology | No | 2012-08-09 |
| Calprotectin, Fecal | NXO | Class 2 | Immunology | No | 2018-10-25 |
| Autoantibodies, Endomysial(Tissue Transglutaminase) | MVM | Class 2 | Immunology | No | 2012-08-09 |
| Instrumentation For Clinical Multiplex Test Systems | NSU | Class 2 | Clinical Chemistry | No | 2021-09-02 |
| Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control | DBM | Class 2 | Immunology | No | 2017-09-11 |
| Anti-Dna Indirect Immunofluorescent Solid Phase | KTL | Class 2 | Immunology | No | 2021-03-01 |
| System, Test, Rheumatoid Factor | DHR | Class 2 | Immunology | No | 2012-08-09 |
| Helicobacter Pylori | LYR | Class 1 | Microbiology | No | 2012-08-09 |
| Anti-Rnp Antibody, Antigen And Control | LKO | Class 2 | Immunology | No | 2013-05-01 |
| Anti-Sm Antibody, Antigen And Control | LKP | Class 2 | Immunology | No | 2013-05-01 |
| Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp) | NHX | Class 2 | Immunology | No | 2012-08-09 |
| Autoantibodies, Nuclear Body Protein, Sp100 | NUM | Class 2 | Immunology | No | 2005-08-22 |
| Antibodies, Anti-Actin, Anti-Smooth Muscle | NJF | Class 2 | Immunology | No | 2009-01-14 |
| Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | LJM | Class 2 | Immunology | No | 2012-08-09 |
| Anti-Ribosomal P Antibodies | MQA | Class 2 | Immunology | No | 2014-04-02 |
| Anti-Dna Antibody, Antigen And Control | LSW | Class 2 | Immunology | No | 2016-04-13 |
| Antinuclear Antibody, Antigen, Control | LKJ | Class 2 | Immunology | No | 2014-05-28 |
| Autoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis | NIY | Class 2 | Immunology | No | 2009-01-14 |
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | Class 1 | Clinical Chemistry | No | 2020-03-05 |
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 2011-08-03 |
| Reagents, Specific, Analyte | MVU | Class 1 | Pathology | No | 2014-01-09 |
| Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae) | NBT | Class 2 | Immunology | No | 2009-01-14 |
| Thyroglobulin, Antigen, Antiserum, Control | DDC | Class 2 | Immunology | No | 2009-01-26 |
| Auto-Antibodies; Phosphatidylserine, Prothrombin, Phosphatidylserine/Prothrombin Complex | OPN | Class 2 | Immunology | No | 2012-08-09 |
| Autoantibodies, Nuclear Pore Glycoprotein Gp210 | NRI | Class 2 | Immunology | No | 2012-08-09 |
| Complement C1q, Antigen, Antiserum, Control | DAK | Class 2 | Immunology | No | 2010-01-14 |
Proprietary Names
QUANTA Lite Intrinsic Factor ELISA
QUANTA Lite dsDNA ELISA
QUANTA Lite ds DNA ELISA double stranded DNA ELISA
QUANTA Lite HMGCR ELISA
PBS Concentrate (40x)
PBS II Concentrate (40x)
Mounting Medium Pack
Mounting Medium
FITC IgA Conjugate
FITC IgG Conjugate
FITC IgG Conjugate Primate Absorbed
FITC IgG Conjugate with DAPI
FITC IgGAM Conjugate
QUANTA Lite SS-A ELISA
QUANTA LIte GPA (Gastric Parietal Cell Antibody) ELISA
QUANTA Lite GPA ELISA (Gastric Parietal Cell Antibody)
QUANTA Lite GPA ELISA
QUANTA Lite LKM-1 ELISA
Aptiva APS IgA Reagent
ANA PCNA Pattern
Pemphigus Positive Control
Atypical ANCA Positive
Pemphigus Positive
Mitochondrial (AMA) Pattern
Endomysial (Celiac) Positive
Smooth Muscle (ASMA) Pattern
Gastric Parietal Cell (GPA) Pattern
QUANTA Lite HA dsDNA ELISA
QUANTA Flash ENA7 Controls
QUANTA Flash ENA7 Control Kit
QUANTA Flash ENA7 Reagent Kit
QUANTA Flash ENA7 Calibrator Kit
QUANTA Flash ENA7 Calibrators
QUANTA Flash ENA7 Reagents
QUANTA Lite SS-A 52 ELISA
QUANTA Lite RNA Pol III ELISA
QUANTA Lite RNA Pol III
NOVA View Automated Fluorescence Microscope with AUTOLoader
NOVA View Automated Fluorescence Microscope
NOVA View
QUATNA Flash SS-B Calibrators
QUATNA Flash SSB Controls
QUANTA Flash SSB Reagents
QUANTA Flash SS-B Controls
QUATNA Flash SS-B Reagents
QUANTA Flash SSB Calibrators
NOVA Lite dsDNA
NOVA Lite dsDNA Crithidia luciliae
QUANTA LIte Gliadin IgG II ELISA Bulk Pack
QUANTA Lite IgG II
QUANTA Lite Gliadin IgG II ELISA
QUANTA Flash PR3 Calibrators
QUANTA Flash PR3 Reagents
QUANTA Flash MPO Calibrators
QUANTA Flash GBM Calibrators
QUANTA Flash MPO Reagents
QUANTA Flash MPO
QUANTA Flash MPO Controls
QUANTA Flash GBM Controls
QUANTA Flash GBM
QUANTA Flash PR3 Controls
QUANTA Flash PR3
QUANTA Flash GBM Reagents
QUANTA Lite B2 GPI IgM ELISA
QUANTA Lite B2 GPI IgM ELISA Bulk Pack
NOVA Lite Rat Liver,Kidney,Stomach
NOVA Lite Rat Liver, Kidney, Stomach Kit
QUANTA Lite Celiac DGP Screen ELISA
QUANTA Lite Celiac DGP Screen
QUANTA Lite PR-3 IgG ELISA
Fecal Extraction Device
QUANTA Lite Jo-1 ELISA
QUANTA Lite h-tTG IgG ELISA (Human Tissue Transglutaminase)
QUANTA Lite h-tTG IgG ELISA
QUANTA Lite h-tTG IgG ELISA Bulk Pack
Aptiva Celiac Disease IgA Reagent
QUANTA Lite h-tTG IgA ELISA Bulk Pack
QUANTA Lite h-tTG IgA ELISA
QUANTA Lite h-tTG IgA ELISA (Human Tissue Transglutaminase)
QUANTA Flash B2GP1 IgM Reagents
QUANTA Flash B2GP1 IgG Reagents
QUANTA Flash B2GP1 IgG
QUANTA Flash B2GP1 IgM Controls
QUANTA Flash B2GP1 IgG Controls
QUANTA Flash B2GP1 IgM
QUANTA Flash Intrinsic Factor Reagents
QUANTA Flash M2 (MIT3) Reagents
QUANTA Flash M2 (MIT3) Controls
QUANTA Flash M2 (MIT3) Calibrators
NOVA Lite DAPI dsDNA Crithidia luciliae Kit
NOVA Lite ANCA (Ethanol Fixed)
NOVA Lite ANCA Substrate Slide Pack
NOVA Lite ANCA Kit
NOVA Lite ANCA
Anti-neutrophil Cytoplasmic Autoantibody Reagents
QUANTA Lite ACA Screen III
QUANTA Lite ACA IgM III ELISA Bulk Pack
QUANTA Lite ACA IgM III
QUANTA Lite RF IgA ELISA
QUANTA Lite H. pylori IgA ELISA
QUANTA Lite PR3 SC ELISA Bulk Pack
QUANTA Lite PR3 SC ELISA
QUANTA Flash Sm Controls
QUANTA Flash Sm Calibrators
QUANTA Flash Sm Reagents
QUANTA Flash RNP Reagents
QUANTA Flash RNP Controls
QUANTA Flash RNP Calibrators
QUANTA Lite CCp3.1 IgG/IgA ELISA Bulk Pack
QUANTA Lite CCP3.1 IgG/IgA ELISA
NOVA Lite ANA KSL
NOVA Lite ANA KSL Kit
QUANTA Flash Ro52 Reagents
QUANTA Flash Ro52
QUANTA Flash Ro52 Controls
QUANTA Flash Ro52 Calibrators
QUANTA Lite ACA IgG III
QUANTA Lite ACA IgG III ELISA Bulk Pack
NOVA Lite DAPI ANCA (Formalin) Kit
NOVA Lite DAPI ANCA (Ethanol) Kit
QUANTA Flash LKM-1 Reagents
QUANTA Flash LKM-1 Calibrators
QUANTA Flash LKM-1 Controls
QUANTA Flash aCL IgA
QUANTA Flash B2 GP1 IgA Controls
QUANTA Flash aCL IgA Controls
QUANTA Flash Cardiolipin IgA Controls
QUANTA Flash Cardiolipin IgA
QUANTA Flash B2 GP1 IgA Reagents
QUANTA Flash aCL IgA Reagents
QUANTA Flash B2 GP1 IgA
QUANTA Flash Cardiolipin IgA Reagents
QUANTA Lite sp100 ELISA
QUANTA Lite RNP ELISA
QUANTA Lite Actin IgG ELISA
QUANTA Lite Actin IgG ELISA Bulk Pack
QUANTA Lite Centromere ELISA
QUANTA Lite Centromere (CENP-A &CENP-B)
QUANTA Lite SS-B ELISA
QUANTA Lite ENA 4 ELISA Sm,RNP, SS-A and SS-B Screening Test
QUANTA Lite ENA 4 ELISA
QUANTA Lite ENA 4
NOVA Lite Autoantibody Controls
Auto AB Panel
NOVA Lite Auto AB Panel
QUANTA Lite Phosphatidylserine IgG ELISA
QUANTA Lite Phosphatidylserine IgM ELISA Bulk Pack
QUATNA Lite Phosphatidylserine IgM ELISA Bulk Pack
QUANTA Lite Phosphatidylserine IgG ELISA Bulk Pack
QUANTA Lite Phosphatidylserine IgM ELISA
QUANTA Lite Phosphatidylserine IgA ELISA
NOVA Lite ANA Plus
NOVA Lite ANA Plus Mouse Kidney & Stomach
QUANTA Lite dsDNA SC ELISA
QUANTA Lite Gliadin IgG ELISA
QUANTA Lite Gliadin IgG ELISA Bulk Pack
NOVA Lite DAPI ANA Kit
QUANTA Flash Ribosomal P Reagents
Aptiva APS IgG Reagent
Aptiva APS IgM Reagent
QUANTA Lite RF IgM ELISA
QUANTA Flash CTD Screen Plus Calibrators
Aptiva Celiac Disease IgA Calibrators
Aptiva Celiac Disease IgG Calibrators
Aptiva APS IgM Calibrators
Aptiva APS IgG Calibrators
Aptiva CTD Essential Calibrators
QUANTA Lite ANA ELISA
Sm,RNP,SS-A,SS-B,Scl-70 & Jo-1 Screening Test
QUANTA Lite ENA 6 ELISA
QUANTA Lite RF IgG ELISA
F-Actin Slide
NOVA Lite IgG F-Actin
QUANTA Flash B2GP1-Domain1
QUANTA Flash B2GP1-Domain1 Reagents
QUANTA Flash B2GP1-Domain1 Controls
HemosIL Acustar Anti-B2GPI-Domain 1 Reagents
HemosIL Acustar Anti-B2GPI-Domain 1 Controls
HemosIL Acustar Anti-B2GPI-Domain 1
Aptiva System
Aptiva Multi-Analyte Instrument
Aptiva Optical Cleaning Solution
Aptiva Optical Control Kit
Aptiva System Rinse
Aptiva System Cleaning Solution Kit
Instrument System Cuvettes
Aptiva Optical Calibrator Kit
QUANTA Lite CCP3 IgG ELISA
QUANTA Lite CCP3 IgG ELISA Bulk Pack
QUANTA Flash dsDNA Reagents
QUANTA Flash dsDNA Controls
QUANTA Flash dsDNA Calibrators
QUANTA Flash dsDNA
QUANTA Flash h-tTG IgA
QUANTA Flash h-tTG IgA Calibrators
QUANTA Flash h-tTG IgA Controls
QUANTA Flash h-tTG IgA Reagents
Aptiva CTD Essential Reagent
QUANTA Lite Scl-70 ELISA
QUANTA Lite TPO ELISA
NOVA Lite IFA Pancreatic Islet Cell Positive Control
NOVA Lite IFA Yo (PCA-1) Positive Control
QUANTA Flash RF IgM Controls
QUANTA Flash RF IgA Controls
QUANTA Flash HMGCR Controls
QUANTA Flash Ribosomal P Controls
QUANTA Flash DFS70 Controls
QUANTA Flash Intrinsic Factor Control
Hu (ANNA-1) Positive Control
NOVA Lite® IFA Hu (ANNA-1) Positive Control
Pancreatic Islet Cell Positive Control
Yo (Purkinje Cell) Positive Control
NOVA View 2
QUANTA Lite MPO IgG ELISA
QUANTA Flash RF IgA Reagents
QUANTA Flash RF IgM
QUANTA Flash RF IgA
QUANTA Flash RF IgM Reagents
QUANTA Lite Calprotectin Extended Range
QUANTA Lite Ribosome P ELISA
QUANTA Lite Gliadin IgA II ELISA
QUANTA Lite Gliadin IgA II ELISA Bulk Pack
QUANTA Lite h-tTG/DGP Screen ELISA
QUANTA Lite h-tTG/DGP Screen
QUANTA Lite H. pylori IgG ELISA
QUANTA Flash CTD Screen Plus Reagents
QUANTA Flash Ribosomal P Calibrators
QUANTA Flash DFS70 Calibrators
QUANTA Flash HMGCR Calibrators
QUANTA Flash Intrinsic Factor Calibrators
QUANTA Flash RF IgA Calibrators
QUANTA Flash RF IgM Calibrators
QUANTA Lite ENA 5 ELISA
Sm,RNP,SS-A,SS-B and Scl-70 Screening Test
QUANTA Lite Sm ELISA
QUANTA Flash CCP3 Reagents
QUANTA Flash CCP3 Controls
QUANTA Flash CCP3 Calibrators
QUANTA Flash CCP3
QUANTA Flash h-tTG IgG Calibrators
QUANTA Flash h-tTG IgG Reagents
QUANTA Flash h-tTG IgG Controls
QUANTA Flash h-tTG
QUANTA Lite SLA ELISA
QUANTA Lite SLA ELISA (Soluble Liver Antigen)
QUANTA Lite SLA
QUANTA Flash Jo-1
QUANTA Flash Jo-1 Calibrators
QUANTA Flash Jo-1 Reagents
QUANTA Flash Jo-1 Controls
QUANTA Lite R h-tTG IgA ELISA Bulk Pack
QUANTA Lite R h-tTG IgA ELISA
QUANTA Lite R h-tTG IgG ELISA
QUANTA Lite R h-tTG IgG ELISA Bulk Pack
QUANTA Flash CTD Screen Plus Controls
Aptiva Celiac Disease IgG Controls
Aptiva Celiac Disease IgA Controls
Aptiva CTD Essential Controls
Aptiva APS IgG Controls
Aptiva APS IgM Controls
Aptiva APS IgA Controls
QUANTA Flash aPL Multi Controls
QUANTA-Lyser 160
QUANTA-Lyser 2
QUANTA-Lyser 3000
QUANTA-Lyser 240
QUANTA-Lyser ELISA/IFA+Incubator
QUANTA-Lyser IFA
QUANTA-Lyser ELISA/IFA
Aptiva Celiac Disease IgG Reagent
QUANTA Flash DGP Screen Reagents
QUANTA Flash DGP Screen Calibrators
QUANTA Flash DGP Screen Controls
QUANTA Flash DGP Screen
QUANTA Flash Centromere Calibrators
QUANTA Flash Centromere Reagents
QUANTA Flash Centromere Controls
QUANTA Lite Chromatin ELISA
Heart (Primate)Slide
Rat Liver/Kidney/Stomach Slide
DFS-70 ELISA Plate
GBM ELISA Calibrator Set
ANCA (Formalin Fixed Human Neutrophil) Slide
NOVA Lite Monkey Oesophagus Slide Pack
Anti-C1q High Positive
NOVA Lite Ovary (Primate) Slide Pack
ANA KSL (Mouse Kidney, Stomach, Liver) Slide
Monkey Oesophagus Slide
ICA (Primate Pancreas)
NOVA Lite Heart (Primate)Slide Pack
ANCA (Ethanol Fixed Human Neutrophil) Slide
NOVA Lite ICA (Primate Pancrease) Slide Pack
dsDNA (Crithidia luciliae) Slide
NOVA Lite ANA KSL Slide Pack
NOVA Lite dsDNA (Crithidia luciliae) Slide Pack
Anti-C1q ELISA Plate
NOVA Lite HEp-2 ANA Slide Pack
HMGCR ELISA Plate
Anti-C1q Low Positive
NOVA Lite Cerebellum (Primate) Slide Pack
HEp-2 ANA Slide
NOVA Lite Rat Liver/Kidney/Stomach Slide Pack
CarP ELISA Plate
Anti-C1q Sample Diluent
Cerebellum (Primate)Slide
Primate Ovary Slide
QUANTA Lite M2 EP (MIT3) ELISA
QUANTA Lite M2 EP (MIT3)
QUANTA Lite M2 EP (MIT3) ELISA Bulk Pack
QUANTA Lite ASCA IgG ELISA
QUANTA Lite ASCA IgG ELISA (S. cerevisiae)
QUANTA Lite ASCA (S.cerevisiae) IgG
QUANTA Lite Thyroid T ELISA
QUANTA Lite B2GP1 IgG ELISA Bulk Pack
QUANTA Lite B2GPI IgG ELISA
QUANTA Lite B2 GPI IgA ELISA Bulk Pack
QUANTA Lite B2 GPI IgA ELISA
QUANTA Lite B2 GPI Screening ELISA
QUANTA Lite B2 GPI Screening ELISA Bulk Pack
QUANTA Flash DGP IgG Controls
QUANTA Flash DGP IgA Reagents
QUANTA Flash DGP IgG Reagents
QUANTA Flash DGP IgG Calibrators
QUANTA Flash DGP IgA Controls
QUANTA Flash DGP IgA Calibrators
QUANTA Lite aPS/PT IgG ELISA
QUANTA Lite aPS/PT IgM ELISA
(anti-phosphatidylserineand prothombin)
QUANTA Lite h-tTG Screen ELISA
QUANTA Lite h-tTG Screen
QUANTA Lite Gliadin IgA ELISA Bulk Pack
QUANTA Lite Gliadin IgA ELISA
QUANTA Lite tTG ELISA
QUANTA Lite tTG ELISA (TissueTransglutaminase)
QUANTA Lite Histone ELISA
QUANTA Lite F-Actin IgA ELISA
QUANTA Lite GBM ELISA
QUANTA Lite GBM ELISA Bulk Pack
NOVA Lite ANCA (Formalin Fixed)
NOVA Lite ANCA (Formalin) Kit with DAPI
NOVA Lite ANCA Formalin Kit
QUANTA Lite PBC Screen IgG/IgA ELISA
QUANTA Flash Scl-70 Reagents
QUANTA Flash Scl-70 Controls
QUANTA Flash Scl-70
QUANTA Flash Scl-70 Calibrators
QUANTA Lite C1q CIC ELISA
QUANTA Flash aCL IgM Controls
QUANTA Flash aCL IgM Reagents
QUANTA Flash aCL IgG Reagents
QUANTA Flash aCL IgG Controls
QUANTA Flash aCL IgG
QUANTA Flash aCL IgM
QUANTA Flash HMGCR Reagents
NOVA Lite Monkey Oesophagus IFA Kit
QUANTA Lite Anti-C1q ELISA
QUANTA Lite gp210 ELISA
QUANTA Lite gp210
QUANTA Lite ASCA IgA ELISA (S. cerevisiae)
QUANTA Lite ASCA IgA ELISA
QUANTA LIte ASCA (S. cerevisiae) IgA
QUANTA Flash Ro60 Controls
QUANTA Flash Ro60 Reagents
QUANTA Flash Ro60 Calibrators
QUANTA Lite ACA IgA ELISA Bulk Pack
QUANTA Lite ACA IgA III
QUANTA Flash Calprotectin Calibrators
QUANTA Flash Calprotectin Reagents
QUANTA Flash Calprotectin
QUANTA Flash Calprotectin Controls
QUANTA Flash Calprotectin Extraction Buffer
NOVA Lite HEp-2 ANA Kit
QUANTA Flash DFS70 Reagents
NOVA Lite DAPI EMA Kit
Establishment Types
Manufacture Medical Device
Manufacture Device in the United States for Export Only
Develop Specifications But Do Not Manufacture At This Facility
Repack or Relabel Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)