FDA Registration
Active
🇺🇸 United States
Abbott Molecular Distribution Center
Reg #: 3019837962
·
FEI: 3019837962
·
Expires 2026
Products
28
Proprietary Names
329
Establishment Types
2
Classifications
28
Registration Details
- Registration Name
- Abbott Molecular Distribution Center
- Registration Number
- 3019837962
- FEI Number
- 3019837962
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 1015 West Devon
- City
- Itasca
- State
- IL
- ZIP
- 60143
- Country
- US
Regulatory Submissions
- 510(k) Number
- K222379
- PMA Number
- BP060002
Owner / Operator
- Firm Name
- ABBOTT LABORATORIES
- Operator Number
- 1415939
- Address
- 100 ABBOTT PARK RD., D-03Q3, AP52-1
- City
- Abbott Park
- State
- IL
- Postal Code
- 60064
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| General Purpose Reagent | PPM | Class 1 | Pathology | No | 1998-06-30 |
| Human Immunodeficiency Virus (Hiv) Viral Load Monitoring Test | QUM | Class 2 | Microbiology | No | 2007-11-26 |
| Fluorescence In Situ Hybridization, Chromosome 17p Deletion (Tp53) | PNK | Class 3 | Unknown | No | 2016-04-15 |
| Reagents, 2019-Novel Coronavirus Nucleic Acid | QJR | Class N | Unknown | No | 2020-03-18 |
| Trichomonas Vaginalis Nucleic Acid Amplification Test System | OUY | Class 2 | Immunology | No | 2019-02-26 |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | Class 1 | Clinical Chemistry | No | 2019-01-30 |
| Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections | QEP | Class 2 | Microbiology | No | 2023-08-21 |
| Dna-Reagents, Neisseria | LSL | Class 2 | Microbiology | No | 2023-08-21 |
| Dna Probe, Nucleic Acid Amplification, Chlamydia | MKZ | Class 1 | Microbiology | No | 2023-08-21 |
| Early Growth Response Gene 1 (Egr1) Fish Probe Kit For Specimen Characterization | PDO | Class 2 | Hematology | No | 2013-12-19 |
| Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples | PGI | Class 2 | Microbiology | No | 2023-08-24 |
| Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement | OWE | Class 3 | Unknown | No | 2011-09-27 |
| Kit, Dna Detection, Human Papillomavirus | MAQ | Class 3 | Unknown | No | 2019-01-30 |
| Dna-Probe Kit, Human Chromosome | OYU | Class 2 | Immunology | No | 2009-12-17 |
| Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus | MZP | Class 2 | Microbiology | No | 2020-04-23 |
| Real Time Nucleic Acid Amplification System | OOI | Class 2 | Clinical Chemistry | No | 2020-04-23 |
| Dna-Reagents, Epstein-Barr Virus | LSF | Class 1 | Microbiology | No | 2015-04-29 |
| Nucleic Acid Amplification Test For The Quantitation Of Bk Virus (Bk) Dna | QMI | Class 2 | Microbiology | No | 2023-09-11 |
| Device, Specimen Collection | LIO | Class 1 | Microbiology | No | 2013-02-21 |
| Assay, Genotyping, Hepatitis C Virus | OBF | Class 2 | Microbiology | No | 2009-12-17 |
| Clinical Sample Concentrator | JJH | Class 1 | Clinical Chemistry | No | 2019-01-30 |
| Cytomegalovirus (Cmv) Dna Quantitative Assay | PAB | Class 2 | Microbiology | No | 2022-05-16 |
| Urine Transport Kit (Excludes Hiv Testing) | OHZ | Class 1 | Pathology | No | 2023-09-11 |
| Test, Fluorescence In Situ Hybridization (Fish), For Bladder Cancer Detection And Monitoring For Recurrence | NSD | Class 3 | Unknown | No | 2007-11-26 |
| Test, Hiv Detection | MZF | Class 2 | Microbiology | No | 2012-06-07 |
| Hepatitis Viral B Dna Detection | MKT | Class 2 | Microbiology | No | 2009-12-17 |
| Dna Fish Probe Kit For Specimen Characterization, Human Chromosome, Hematological Disorders | PFG | Class 2 | Hematology | No | 2013-11-25 |
| Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents | QOF | Class 2 | Microbiology | No | 2025-06-25 |
Proprietary Names
DAPI I Counterstain (1000 ng/mL) 500 ?L x 2
Antibody Diluent 2.5X DF with 2X NAD and G6P GPR (100 mL)
Enzyme Conjugate Diluent 2.5X DF with Low Sodium Bisulfite GPR (600 mL)
Enzyme Conjugate Diluent 2X DF with Low Sodium Bisulfite GPR (40 mL)
CGH Target Slides
Higher pH Antibody Diluent DF 2X NAD and G6P GPR (100 mL)
VP 2000 Pretreatment Reagent (500 mL)
Lower pH Enzyme Conjugate Diluent DF GPR (600 mL)
Enzyme Conjugate Diluent DF GPR (700 mL)
Alcohol Diluent GPR 60 mL
VYSIS Paraffin Pretreatment Reagent KIT
Enzyme Conjugate Diluent 2X DF with Low Sodium Bisulfite GPR (400 mL)
Higher pH Antibody Diluent DF 2X NAD and G6P GPR (1000 mL)
VP 2000 Protease I (250 mg x 2)
NICK Translation Kit
Abbott Proteinase K
SpectrumGreen Male Reference DNA
Paraffin Pretreatment Kit III
Protease Buffer II
Gold dUTP
rTth Polymerase
DNA Activation Reagent
SpectrumRed Female Reference DNA
CEP Hybridization Buffer
VP 2000 Protease Buffer (500 mL)
SpectrumGreen Female Reference DNA
AMP Check E GPR
Master Mix E GPR
ProbeChek MultiVysion Control Slides
Abbott Bisulfite Modification Kit
Vysis IntelliFish FFPE Tissue Pretreatment Protease (for 50mL)
Vysis IntelliFish Universal FFPE Tissue Pretreatment and Wash
Vysis IntelliFish Hybridization Buffer 1x250 uL
Vysis IntelliFish FFPE Tissue Pretreatment Protease (for 500mL)
Vysis IntelliFish Hybridization Buffer 5x250 uL
Abbott mSample Preparation System Bulk mLysis DNA Buffer
Alinity h-series AutoClean Solution (LN 01R5104)
DAPI II Counterstain (125 ng/mL)
VP 2000 Reagents ? Protease II (750 mg) 750 mg
Orange dUTP
Aqua dUTP
20X SSC, 500g
RNA AMP Check
VYSIS PARAFFIN PRETREATMENT KIT I
SpectrumRed Male Reference DNA
CGH NICK Translation Reagent Set
VP 2000 Reagents ? 2N MgCl 2 (120 mL)
DAPI III Counterstain (42 ng/mL) 500 ?L x 2
LSI®/WCP® Hybridization Buffer
Hemo-De Solvent
CGH NICK TRANSLATION REAGENTSET
DNA AMP Check
CGH Hybridization Reagent Kit Assembly
Human Cot-1 DNA, 250 uL For Laboratory Use
RNA Activation Reagent
SpectrumGreen CGH Control DNA (MPE 600)
NP-40 1000µL x 2
Red dUTP
Antibody Diluent DF 2X NAD and G6P GPR (1000 mL)
Enzyme Conjugate Diluent DF GPR (70 mL)
Antibody Diluent DF with Low NAD & G6P 2X NAD & G6P GPR (1000 Ml)
HEIA Enzyme Conjugate Diluent DF GPR (100 mL) HEIA Enzyme Conjugate Diluent DF GPR (1000 mL)
HEIA Enzyme Conjugate Diluent DF GPR (100 mL)
Green dUTP
LSI®/WCP® Hybridization Buffer 2 x 500 ?L, For Laboratory Use
Lower pH Enzyme Conjugate Diluent DF GPR (60 mL)
Enzyme Conjugate Diluent 2X DF with Low Sodium Bisulfite GPR (60 mL)
Enzyme Conjugate Diluent DF with Sodium Bisulfite GPR (100 mL)
Enzyme Conjugate Diluent DF with Sodium Bisulfite GPR (1000 mL)
Antifade II Solution 60 ?L x 2
Taq Gold Polymerases
Pretreatment Reagent 500 mL
Enzyme Conjugate Diluent DF GPR (600 mL)
Propidium Iodide Counterstain
CGH Control DNA (MPE 600) Unlabeled
Enzyme Conjugate Diluent DF GPR (60 mL)
Paraffin Pretreatment Kit II
FISH Specimen Pretreatment Reagent Kit
Antifade Solution, 2 x 240 µL For Laboratory Use
Antifade II Solution, 2 x 60 uL, For Laboratory Use
VP 2000 Reagents ? 20X SSC (500 g)
Antibody Diluent DF 2X NAD and G6P GPR (100 mL)
VYSIS FISH Specimen Pretreatment Reagent Kit
Antibody Diluent 2.5X DF with 2X NAD and G6P GPR (1000 mL)
Abbott RealTime HIV-1 Control Kit
Abbott RealTime HIV-1 Calibrator Kit
Abbott RealTime HIV-1
Abbott RealTime HIV-1 Control Kit 06L18-080
HIV-1 UNG Extended Use 06L18-067, 6L87-02
Abbott RealTime HIV-1 Calibrator Kit 06L18-070
Abbott RealTime HIV-1 Extended Use 06L18-050
Abbott RealTime HIV-1 Amplification Reagent Kit 06L18-090
Abbott RealTime HIV-1 CD ROM 06L83
Abbott RealTime HIV-1 Including UNG 06L18-066, 6L87-02
Amplification Reagent Kit
Vysis CLL FISH Probe Kit
Abbott Bulk Universal Collection Kit (List 09N92-010)
Alinity m STI Control Kit
Alinity m STI Application Specification File
Alinity m STI Amplification Reagent Kit
Alinity m Ethanol Solution
Alinity n Sample Tip (LN 0TN43-01)
Alinity n Amplification Vessel (LN 0TN41-01)
Alinity n Wash Vessel (LN 0TN42-01)
Alinity m Transport Tube
Alinity m Transport Tube Pierceable Capped
Alinity m LRV Tube
Alinity m Pierceable Cap
Alinity m Aliquot Tube
Alinity m Bottle for Ethanol Use
Alinity n Eluate Tip (LN 0TN44-01)
Alinity n Lysis Tube and Tip (LN 0TN40-01)
Alinity m System
Alinity m Lysis Solution
Alinity m Multi-Collect Specimen Collection Kit
Alinity m Diluent Solution
Alinity m Sample Prep Kit 1
Alinity m Vapor Barrier Solution
Vysis EGR1 FISH Probe Kit SC (Specimen Characterization) (04N37-001)
Alinity m HSV 1 & 2 / VZV Control Kit
Alinity m HSV 1 & 2 / VZV Amplification Reagent Kit
Alinity m HSV 1 & 2 / VZV Application Specification File
Vysis ALK Break Apart FISH Probve Kit
ProbeCheck ALK Negative Control Slides
ProbeCheck ALK Negative Control Slides 06N38-005
Vysis ALK Break Apart FISH Probe Kit (06N38-053)
Vysis ALK Break Apart FISH Probe Kit (06N38-033)
ProbeCheck ALK Positive Control Slides 06N38-010
Vysis ALK Break Apart FISH Probe Kit 06N38-020
Vysis Paraffin Pretreatment IV and Post Hybridization Wash Buffer Kit 01N31-005
VP2000 Pretreatment Kit (08N16-001)
ProbeCheck ALK Positive Control Slides
Post Hybridization Wash Buffer Kit
Vysis Paraffin Pretreatment IV &
simpli-COLLECT HPV Collection Kit (09R03-040)
Alinity m HR HPV Application Specification File
Alinity m HR HPV Amplification Kit, Alinity m HPV Control Kit
Alinity m HR HPV AMP Kit (List 09N15-092)
Alinity m Specimen Buffer Kit III
Alinity m Specimen Buffer Kit II
simpli-COLLECT HPV Collection Kit (LN 09R03-033)
simpli-COLLECT HPV Collection Kit
simpli-COLLECT HPV Collection Kit (09R03-035)
Aneuvysion DNA Probe Kit (05J38-010, 05J38-030, 05J38-050)
Probe Check Prenatal Positive Control Slide (05J36-005)
Probe Check Normal Male Amniocyte Control Slide (05J39-005)
Aneuvysion Prenatal Kit
Abbott RealTime CT/NG Assay and Multi-Collection Kit, Abbott RealTime CT/NG Assay including UNG. 6L87-02
Abbott RealTime CT/NG Assay and Multi-Collection Kit
Abbott RealTime EBV Abbott RealTime EBV Calibrator Kit Abbott RealTime EBV m2000 System ROW Combined Application CDROM
Alinity m EBV Calibration Kit 09N43-70
Alinity m EBV Amplification Reagent Kit 09N43-091
Alinity m EBV Application Specification File 09N43-03A
Alinity m EBV Amplification Reagent Kit 09N43-90
Alinity m EBV Control Kit 09N43-80
Alinity m EBV Application Specification File 09N43-07A
Alinity m EBV WB CTRL Kit 09N43-082
Alinity m EBV WB AMP Kit 09N43-092
Alinity m EBV WB Application Specification File 09N43-09A
Alinity m EBV WB CAL Kit 09N43-072
Alinity m STI Amplification Kit, Alinity m STI Control Kit
Alinity m STI Application Specification File List 09N17-05A
Alinity m Multi-Collect Specimen Collection Kit List 09N19-010
Alinity m BKV Application Specification File
Alinity m BKV Control Kit
Alinity m BKV Calibrator Kit
Alinity m BKV Amplification Reagent Kit
Alinity m Cervi Collect Specimen Collection Kit
Alinity m Multi Collect Specimen Collect Kit
Abbott Realtime HCV GT II
Alinity m Sample Prep 1
Abbott m24sp
Alinity m CMV Amplification Reagent Kit
Alinity m Specimen Dilution Kit I
Alinity m CMV Calibrator Kit
Alinity m CMV Application Specification File
Alinity m CMV Control Kit
Alinity m Sample Prep Kit 2
UroVysion Bladder Cancer Kit (Kit with 20 / 100 tests)
Vysis FUS Break Apart FISH Probe Kit
Vysis DDIT3 Break Apart FISH Probe Kit
Vysis Melanoma FISH Probe Kit
Vysis MYC Break Apart FISH Probe Kit
Vysis ETV6/RUNX1 DF FISH Probe Kit
Vysis EGFR/CEP 7 FISH Probe Kit
Vysis ZNF217 SpectrumRed FISH Probe Kit
Vysis RUNX1/RUNX1T1 DF FISH Probe Kit (Vysis LSI AML1/ETO Dual Color, Dual Fusion Translocation Probe)
Vysis PIK3CA SpectrumGreen FISH Probe Kit
PathVysion HER-2 DNA Probe Kit II, 20 assay for Gastric Her 2
MultiVysion PB Multi-Color Probe Set
Vysis RPN1/MECOM DF FISH Probe Kit
Vysis D7S522/CEP 7 FISH Probe Kit
PathVysion HER-2 DNA Probe Kit II, 100 assay for Gastric Her 2
Vysis LSI PMLRARA Dual Color, Dual Fusion Translocation Probe Set
Vysis AURKA SpectrumGold FISH Probe Kit
Vysis TRA/D Break Apart FISH Probe Kit
Vysis LSI IGH/BCL2 Dual Color, Dual Fusion Translocation Probe Set
Vysis LSI ATM (11q22.3) SpectrumOrange Probe
Vysis BCL2 Break Apart FISH Probe Kit
Vysis SS18 Break Apart FISH Probe Kit
Vysis TP53/CEP 17 FISH Probe Kit
Vysis TOP2A/CEP 17 Fish Probe Kit
Vysis ZNF217 SpectrumGold FISH Probe Kit
Vysis LSI BCR/ABL Dual Color, Dual Fusion Translocation Probe Set, 50 Assays
ProbeChek Control Slides for UroVysion Bladder Cancer Kit
Vysis IGH/FGFR3 DF FISH Probe Kit
Vysis Prader-Willi/Angelman Region D15S10/CEP 15/PML FISH Probe Kit
Vysis LSI p53/LSI ATM and LSI D13S319/ LSI 13q34/CEP 12 Multi-Color Probe Sets
Vysis LSI D13S25 (13q14.3) Spectrum Orange Probe
Vysis BRAF SpectrumGold FISH Probe Kit
Vysis MultVysion PGT Multi-Color FISH Probe Kit
Vysis LSI BCR/ABL Dual Color, Dual Fusion Translocation Probe Set, 20 Assays
Vysis RARA Break Apart FISH Probe Kit
Vysis BIRC3/MALT1 DF FISH Probe Kit
Vysis Cervical FISH Probe Kit
Vysis MYB SpectrumAqua FISH Probe Kit
Vysis LSI 13 (13q14) SpectrumGreen
Vysis PTEN /CEP 10 FISH Probe Kit
Vysis IGH/CCND1 DF FISH Probe Kit
Vysis 13q34 SpectrumGreen FISH Probe Kit
Vysis CSF1R/D5S23, D5S721 FISH Probe Kit
Vysis CBFB Break Apart FISH Probe Kit
Vysis LSI BCR/ABL Dual Color, Singlel Fusion Translocation Probe Set
Vysis ETV6 Break Apart FISH Probe Kit
Vysis EWSR1 Break apart FISH Probe Kit
Vysis LSI RB1 (13q14) SpectrumOrange Probe
Vysis CCND1 Break Apart FISH Probe Kit
Vysis MALT1 Break Apart FISH Probe Kit
Vysis ATM/CEP 11 FISH Probe Kit
Vysis LSI IGH Dual Color, Break Apart Rearrangement Probe
Vysis 1p36/1q25 and 19q13/19p13 FISH Probe Kit
Vysis ZNF217 SpectrumOrange FISH Probe Kit
PathVysion HER-2 DNA Probe Kit II, 50 assay for Gastric Her 2
Vysis LSI TUPLE1 (HIRA) SpectrumOrange/LSI ARSA SpectrumGreen Probe Set
Vysis 4q12 Tri-Color Rearrangement FISH Probe Kit
Vysis LSI EGR1/D5S23, D5S721 Dual Color Probe Set
Vysis ToTelVysion Multi-color FISH Probe Kit
Vysis PML/RARA SF FISH Probe Kit
Vysis LSI 21 SpectrumOrange Probe
Vysis LSI D13S319 (13q14.3) SpectrumOrange Probe
Vysis MYC SpectrumOrange FISH Probe Kit
Vysis BCR/ABL1/ASS1 Tri-Color DF FISH Probe Kit
Vysis SRY/CEP X FISH Probe Kit
Vysis IGH/MYC/CEP 8 Tri-Color DF FISH Probe Kit
Vysis CCND1/CEP 11 FISH Probe Kit
Vysis ALK Break Apart FISH Probe Kit ProbeChek ALK Negative Control Slides ProbeChek ALK Positive Control Slides
Vysis IGH/MAF DF FISH Probe Kit
Vysis LSI MLL Dual Color, Break Apart Rearrangement Probe
Vysis MET SpectrumRed FISH Probe Kit
Vysis LSI BCR/ABL ES Dual Color Translocation Probe Set
Vysis D20S108 FISH Probe Kit
Vysis TOP2A/HER-2/CEP 17 FISH Probe Kit
Vysis D13S319/13q34 FISH Probe Kit
Vysis D7S486/CEP 7 FISH Probe Kit
Vysis 9q34 SpectrumAqua FISH Probe Kit
Vysis IGH/MALT1 DF FISH Probe Kit
BCR/ABL 9q34 Tricolor, Dual Fusion Translocation Probe
Vysis LSI p53 (17p13.1) SpectrumOrange Probe
Vysis Esophageal FISH Probe Kit
Vysis FOXO1 Break Apart FISH Probe Kit
Vysis D5S23, D5S721/CEP 9/CEP 15 FISH Probe Kit
Vysis PDGFRB Break Apart FISH Probe Kit
Vysis Prader-Willi/Angelman Region SNRPN/CEP 15/PML FISH Probe Kit
Vysis LSI ETV6 (TEL)/RUNX1 (AML) ES Dual Color, Translocation Probe Set
Vysis MDM2/CEP 12 FISH Probe Kit
Vysis CDKN2A /CEP 9 FISH Probe Kit (Vysis LSI p16 (9p21)/CEP 9 Dual Color Probe)
Vysis IGH/CCND1 XT DF FISH Probe Kit
Vysis Williams Region Probe ELN/D7S486, D7S522 FISH Probe Kit
Alinity m HR HPV CTRL Kit
Alinity m HR HPV AMP Kit
simpli-COLLECT HPV Collection Kit (09R16-001)
Alinity m Urine Transport Kit
UroVysion Bladder Cancer Kit, 100 Assay 02J27-095
UroVysion Bladder Cancer Kit, 20 Assay 02J27-025
ProbeChek Slides 02J27-011
UROVYSION BLADDER C ANCER KIT
HIV-1 CD-ROM (01L68)
m2000 System 13mm DBS PoSt Set
Abbott mSample Preparation System DBS Buffer Kit
Abbott RealTime HIV-1 Amplification Reagent Kit
Abbott RealTime HIV-1 Qualitative CD-Rom
HIV-1/HCV maxCycle CD ROM (03N23)
Alinity m Specimen Dilution Kit
Alinity m HIV-1 Application Specification File
Alinity m HIV-1 Amplification Kit, Alinity m HIV-1 Control Kit, Alinity m HIV-1 Calibrator Kit
Alinity m HIV-1 Application Specification File for DBS Supplement v2
Dried Blood Spot (DBS) Supplement v2 to the Alinity m HIV-1 Assay (LN 08N45-040)
Alinity m HIV-1 Application Specification File for DBS Supplement
Abbott RealTime CMV CD Rom 09N21
Abbott RealTime CMV Calibrator Kit 09N21-070
Abbott RealTime CMV Amplification Reagent Kit 9N21-090
Abbott RealTime CMV Control Kit 09N21-080
Abbott Realtime HBV
Alinity m HBV Application Specification File
Alinity m HBV Amplification Kit, Alininty m HBV Control Kit, Alinity m HBV Calibrator Kit
VYSIS D7S486/CEP 7 FISH PROBE KIT (04N78-020)
Abbott Realtime HCV
Abbott RealTime HCV CD-ROM
Alinity m HCV Control Kit
Alinity m HCV Amplification Reagent Kit
Alinity m HCV Application Specification File
Alinity m HCV Calibrator Kit
Alinity m Resp-4-Plex Application Specification File
Alinity m Resp-4-Plex CTRL Kit
Alinity m Resp-4-Plex AMP Kit
Abbott MultiCollect Specimen Collection Kit 09K12
Abbott RealTime CT/NG Amplification Reagent Extended Use with Pierceable Cap (08L07-050)
Abbott m2000 System Chlamydia Trachomatis and Neisseria Gonorrhoeae Application CD-ROM 06L98
Abbott m2000 System Chlamydia trachomatis and Neisseria gonorrhoeae application CD ROM ver 5 (6L98-05)
Abbott RealTime CT/NG Amplification Reagent Kit 08L07-91
Abbott RealTime CT/NG Control Kit 08L07-80
Abbott RealTime CT/NG Amplification Including UNG (08L07-66)
Abbott Real Time CT/NG Amplification Reagent Extended Use Including UNG (08L07-067)
Abbott RealTime CMV Calibrator Kit (5N23-70)
Abbott RealTime CMV/EBV maxCycle with Aplification Extended Use (9N04-050)
Abbott RealTime CMV m2000 System ROW Combined Application CD-Rom Ver 3(5N23-03)
Abbott RealTime CMV m2000 System ROW Combined Application CD-ROM)5N23-02)
Abbott RealTime CMV m2000 System ROW Combined Application CD-ROM (5N23-01)
Abbott RealTime CMV Control Kit (5N23-80)
Abbott RealTime CMV Amplification Reagent Kit (5N23-90)
Alinity m CMV Calibration Kit 09N46-70
Alinity m CMV Amplification Reagent Kit 09N46-90
Alinity m CMV Application Specification File (Plasma)
Alinity m CMV Application Specification File (Whole Blood) 09N46-03B
Alinity m CMV Control Kit 09N46-80
Alinity m CMV WB Application Specification File 09N46-07A
Alinity m CMV WB CTRL Kit (09N46-082)
Alinity m CMV WB CAL Kit (09N46-072)
Alinity m CMV WB AMP Kit (09N46-092)
Establishment Types
Manufacture Medical Device
Manufacture Device in the United States for Export Only