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
General Purpose Reagent PPM
Human Immunodeficiency Virus (Hiv) Viral Load Monitoring Test QUM
Fluorescence In Situ Hybridization, Chromosome 17p Deletion (Tp53) PNK
Reagents, 2019-Novel Coronavirus Nucleic Acid QJR
Trichomonas Vaginalis Nucleic Acid Amplification Test System OUY
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use LXG
Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections QEP
Dna-Reagents, Neisseria LSL
Dna Probe, Nucleic Acid Amplification, Chlamydia MKZ
Early Growth Response Gene 1 (Egr1) Fish Probe Kit For Specimen Characterization PDO
Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples PGI
Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement OWE
Kit, Dna Detection, Human Papillomavirus MAQ
Dna-Probe Kit, Human Chromosome OYU
Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus MZP
Real Time Nucleic Acid Amplification System OOI
Dna-Reagents, Epstein-Barr Virus LSF
Nucleic Acid Amplification Test For The Quantitation Of Bk Virus (Bk) Dna QMI
Device, Specimen Collection LIO
Assay, Genotyping, Hepatitis C Virus OBF
Clinical Sample Concentrator JJH
Cytomegalovirus (Cmv) Dna Quantitative Assay PAB
Urine Transport Kit (Excludes Hiv Testing) OHZ
Test, Fluorescence In Situ Hybridization (Fish), For Bladder Cancer Detection And Monitoring For Recurrence NSD
Test, Hiv Detection MZF
Hepatitis Viral B Dna Detection MKT
Dna Fish Probe Kit For Specimen Characterization, Human Chromosome, Hematological Disorders PFG
Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents QOF

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