FDA Registration
Active
🇺🇸 United States
Beckman Coulter, Inc.
Reg #: 2919016
·
FEI: 2919016
·
Expires 2026
Products
17
Proprietary Names
314
Establishment Types
4
Classifications
17
Registration Details
- Registration Name
- Beckman Coulter, Inc.
- Registration Number
- 2919016
- FEI Number
- 2919016
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1584 Enterprise Blvd
- City
- West Sacramento
- State
- CA
- ZIP
- 95691
- Country
- US
Regulatory Submissions
- 510(k) Number
- K020627
Owner / Operator
- Firm Name
- BECKMAN COULTER, INC.
- Operator Number
- 2050012
- Address
- 250 S. Kraemer Blvd, --
- City
- Brea
- State
- CA
- Postal Code
- 92821
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Panels, Test, Susceptibility, Antimicrobial | LTT | Class 2 | Microbiology | No | 2015-02-23 |
| Manual Antimicrobial Susceptibility Test Systems | JWY | Class 2 | Microbiology | No | 2016-04-19 |
| Susceptibility Test Cards, Antimicrobial | LTW | Class 2 | Microbiology | No | 2015-02-23 |
| Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems | LRG | Class 2 | Microbiology | No | 2015-02-23 |
| Gram Negative Identification Panel | LQM | Class 1 | Microbiology | No | 2015-02-24 |
| System, Test, Automated, Antimicrobial Susceptibility, Short Incubation | LON | Class 2 | Microbiology | No | 2023-04-26 |
| Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth | JTZ | Class 2 | Microbiology | No | 2015-02-23 |
| Colorimeter, Photometer, Spectrophotometer For Clinical Use | JJQ | Class 1 | Clinical Chemistry | No | 2015-02-23 |
| Kit, Anaerobic Identification | JSP | Class 1 | Microbiology | No | 2015-02-23 |
| Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples | SAN | Class 2 | Microbiology | No | 2024-07-29 |
| Gram Positive Identification Panel | LQL | Class 1 | Microbiology | No | 2015-02-24 |
| Kit, Identification, Yeast | JXB | Class 1 | Microbiology | No | 2015-02-23 |
| Medical Device Data System | OUG | Class 1 | General Hospital | No | 2015-02-24 |
| Device, Microtiter Diluting/Dispensing | JTC | Class 1 | Microbiology | No | 2015-02-24 |
| Reagent/Device, Inoculum Calibration | LIE | Class 2 | Microbiology | No | 2023-07-12 |
| Device, General Purpose, Microbiology, Diagnostic | LIB | Class 1 | Microbiology | No | 2022-01-28 |
| Culture Media, Non-Selective And Non-Differential | JSG | Class 1 | Microbiology | No | 2015-02-24 |
Proprietary Names
MicroScan MICroSTREP plus
Panels - Gatifloxacin
MicroScan MICroSTREP plus Panels - Azithromycin
MicroScan MICroSTREP plus Panels - Clindamycin
MicroScan MICroSTREP plus Panels - Moxifloxacin
MicroScan MICroSTREP plus Panels - Tetracycline
MicroScan Dried Gram Positive MIC/Combo Panels - Vancomycin
MicroScan Dried Gram Negative MIC/Combo Panels - Ampicillin
MicroScan Dried Gram Positive MIC/Combo Panels - Synercid
MicroScan MICroSTREP plus Panels - Penicillin
MicroScan HNID Indole Reagent 30ml
MicroScan 10% Ferric Chloride 250ml
MicroScan Rapid Neg ID Panel Type 3
MicroScan HNID Panel
MicroScan Kovacs Reagent 250ml
MicroScan 0.8% Sulfanilic Acid 30ml
MicroScan Rapid Neg ID Panel Type 4
MicroScan 0.5% N,N-Dimethylalphanaphthylamine 30ml
MicroScan Dried Gram Negative Combo Panels
MicroScan 0.5% N,N-Dimethylalphanaphthylamine 250ml
MicroScan 40% Potassium Hydroxide 30ml
MicroScan Mineral Oil 250ml
MicroScan 40% Potassium Hydroxide 250ml
MicroScan Kovacs Reagent 30ml
MicroScan 0.8% Sulfanilic Acid 250ml
MicroScan Mineral Oil 60ml
MicroScan Peptidase 250ml
MicroScan Alpha Naphthol 1.5g
MicroScan Rapid Indole Reagent-F 30ml
MicroScan 10% Ferric Chloride 30ml
MicroScan Neg ID Panel Type 2
MicroScan Peptidase 30ml
VITEK REVEAL BC GN01-AST
MicroScan MICroSTREP plus Panels - Cefuroxime
MicroScan MICroSTREP plus Panels - Ceftriaxone
MicroScan Dried Gram Positive MIC/Combo Panels - Erythromycin
MicroScan MICroSTREP plus Panels - Ampicillin
MicroScan MICroSTREP plus Panels - Linezolid
MH BROTH with 3% LHB
MicroScan Dried Gram-Negative MIC/Combo Panels - Aztreonam
MicroScan Dried Gram-Negative MIC/Combo Panels - Ciprofloxacin
MicroScan Dried Gram Positive MIC/Combo Panels - Meropenem
MicroScan Dried Gram Negative MIC/Combo Panels - Cefepime
MicroScan Dried Gram Positive MIC/Combo Panels - Cefepime
MicroScan Dried Gram Negative ESBL Confirmation Panel - Cefepime
MicroScan MICroSTREP plus Panels - Trimethoprim/Sulfamethoxazole
MicroScan MICroSTREP plus Panels - Vancomycin
MicroScan MICroSTREP plus Panels - Cefotaxime
MicroScan Dried Gram Negative MIC/Combo Panels - Cefpodoxime
MicroScan autoSCAN-4
MicroScan MICroSTREP plus Panels - Erythromycin
MicroScan MICroSTREP plus Panels - Chloramphenicol
MicroScan Dried Gram Positive MIC/Combo Panels
MicroScan Dried Gram Negative MIC/Combo Panels
MicroScan Dried Gram Negative MIC/Combo Panels- Minocycline
MicroScan Dried Gram-Negative MIC/Combo Panels - Levofloxacin
MicroScan Dried Gram Positive MIC/Combo Panels - Ampicillin
MicroScan Dried Gram Negative MIC/Combo Panels - Cefotaxime
MicroScan Dried Gram Negative MIC/Combo Panels - Ceftazidime / Clavulanic acid
MicroScan Dried Gram Negative MIC/Combo Panels - Cefotaxime / Clavulanic acid
MicroScan Dried Gram Negative MIC/Combo Panels - Ceftazidime
MicroScan Dried Gram Negative MIC/Combo Panels - ESBL Screen - Cefotaxime
MicroScan Dried Gram Negative MIC/Combo Panels - ESBL Screen - Ceftazidime
MicroScan Dried Gram Negative MIC/Combo Panels - ESBL Screen - Ceftriaxome
MicroScan Dried Gram Negative MIC/Combo Panels - ESBL Screen - Cefpodoxime
MicroScan WalkAway-40 plus (PN B1018-283)
MicroScan WalkAway-96 plus (PN B1018-284)
DxM 1096 MicroScan WalkAway Instrument (PN B1018-496)
DxM 1040 MicroScan WalkAway Instrument (PN B1018-440)
MicroScan MICroSTREP plus Panels with Tetracycline
MicroScan MICroSTREP plus Panels - Cefepime
MicroScan Dried Gram Positive MIC/Combo Panels - Penicillin
MicroScan MICroSTREP plus Panels - Meropenem
MicroScan MICroSTREP plus Panels -Cefotaxime
MicroScan MICroSTREP plus Panels - Cefaclor
MicroScan HTM BROTH
MicroScan Rapid Anaerobe ID Panel
D31063 MicroScan LabPro Connect V54 System DVD Kit (MR)
D31061 MicroScan LabPro Connect V54 System DVD Kit (JP)
D31050 MicroScan LabPro Connect V54 System (FMR), Electronic
D31062 MicroScan LabPro V54 System DVD Kit (MR)
D31065 MicroScan LabPro Connect V54 System DVD Kit (FMR)
D31045 MicroScan LabPro V54 System (MR), Electronic
D31064 MicroScan LabPro V54 System DVD Kit (FMR)
D23504 MicroScan HighFlexX Software x2.9.2, Electronic
C90683 LabPro V5 Panel Update 10 (FMR), Electronic
C24164 MicroScan LabPro V5 System DVD Kit (JP)
C24166 MicroScan LabPro V5 System DVD Kit (MR)
C90685 MicroScan LabPro V5 Panel Update 10 DVD Kit (FMR)
C24165 MicroScan LabPro Connect V5 System DVD Kit (JP)
D15062 MicroScan LabPro Connect v52 System (JP), Electronic
D14981 MicroScan LabPro v52 System (JP), Electronic
C38722 MicroScan LabPro Connect V5 System DVD Kit (FMR)
D31041 MicroScan LabPro V54 System (JP), Electronic
D31060 MicroScan LabPro V54 System DVD Kit (JP)
D31042 MicroScan LabPro Connect V54 System (JP), Electronic
C54389 MicroScan HighFlexX Software v2.9, Electronic
D31046 MicroScan LabPro Connect V54 System (MR), Electronic
B1018-340R MicroScan WA 40 Plus Reconditioned
C38721 MicroScan LabPro V5 System DVD Kit (FMR)
B1018-396R MicroScan WA 96 Plus Reconditioned
C24167 MicroScan LabPro Connect V5 System DVD Kit (MR)
D31049 MicroScan LabPro V54 System (FMR), Electronic
MicroScan MICroSTREP plus Panels - Amoxicillin/Clavulanic acid
MicroScan Pos Combo 2T
MICroSTREP Plus Panel Type 5
MicroScan Neg BP Combo Panel Type 49
MicroScan Dried Gram Negative Breakpoint Combo Panel Type 42
MicroScan MICroFAST 7J
MicroScan Neg Combo EN 2J
MicroScan Dried Gram Pos BPCombo 3.2J (M)
MicroScan Dried Gram Negative Combo Panel Type 58
MicroScan Dried Gram Negative Combo Panel Type 54
MicroScan Neg MIC EN 2J
MicroScan Neg Combo NF 3T
MicroScan Neg Breakpoint Combo 50
MicroScan Neg Combo NF 3J
MicroScan Dried Gram Positive Combo Panel Type 31
MicroScan Neg MIC EN 52
MicroScan Pos MIC 2J
MicroScan Dried Gram Positive Combo Panel Type 38
MicroScan Pos Combo Panel Type 41
MICroSTREP Plus Panel Type 3
MicroScan Pos Combo Panel Type 42
MicroScan Neg Urine Combo Panel Type 69
MicroScan Pos MIC E 37
MicroScan Neg Combo NF 2J
MicroScan Neg Entero Combo Panel Type 70
MicroScan Neg MIC 2J
MicroScan Neg Bkpt Combo Panel Type 48
MicroScan Pos MIC Panel Type 33
MicroScan Pos MIC STA 35
MicroScan Neg Combo OUT 2J
MicroScan Dried Gram Positive Combo Panel Type 32
MicroScan Dried Gram Negative Urine Combo Panel Type 52
MicroScan Neg Combo IN 2J
MicroScan Dried Gram Negative BP Combo Panel Type 46
MicroScan Neg Combo EN 2T
MicroScan MICroSTREP plus Panel Type 6
MicroScan Dried Gram Negative Urine Combo Panel Type 57
MicroScan Dried Gram Pos BP Combo 3.2J
MicroScan Dried Gram Positive BP Combo Panel Type 28
MicroScan Dried Gram Positive Combo Panel Type 37
MicroScan Neg Combo Panel Type 72
MicroScan Neg Non Entero Combo Panel Type 71
MicroScan MICroFAST Panel Type 6J
MicroScan Dried Gram Positive BP Combo Panel Type 32
MicroScan Negative MIC EN 47
MicroScan Neg Combo Panel Type 66
MicroScan Neg MIC Panel Type 43
MicroScan Dried Gram Positive MIC Panel Type 32
MicroScan Pos Combo Panel Type 39
MicroScan Neg MIC Panel Type 44
MicroScan Dried Gram Negative Urine Combo Panel Type 59
MicroScan Pos Combo 1J
MicroScan Neg MIC EN 3J
MicroScan Neg Combo 82
MicroScan Neg MIC NF 1J
MicroScan Neg Combo Panel Type 63
MicroScan Pos Breakpoint Combo 1J
MicroScan Dried Gram Pos Combo Panel Type 3.1C
MicroScan Neg Combo EN 3J
MicroScan Negative MIC NF 50
MicroScan Pos MIC 1J
MicroScan Dried Gram Pos Combo Panel Type 3.1J
MicroScan Neg Breakpoint Combo 4J
MicroScan Neg Combo 83
MicroScan Neg Breakpoint Combo 2J
MicroScan Dried Gram Negative MIC Panel Type 40
MicroScan Neg Combo EN 2C
MicroScan Neg Urine Combo 81
MicroScan Neg Combo NF 3J (M)
MicroScan Neg MIC EN 51
MicroScan Dried Gram Negative Combo Panel Type 53
MicroScan Pos MIC STA 36
MicroScan Neg Combo EN 4J
MicroScan Neg Combo EN 4J (M)
MicroScan MSF FAST MIC Panel Type 2
MicroScan Neg Multidrug Resistant MIC 1
MicroScan MSF POS MIC Panel Type 2
MicroScan MSF Neg/Pos ID Panel Type 2
MicroScan MSF NEG MIC Panel Type 2
MicroScan Neg MIC 57
MicroScan Neg MDR Combo 100
MicroScan Neg MIC Panel Type 63
MicroScan Neg Combo 99
MicroScan Pos Combo Panel Type 49
MicroScan Negative MIC NF 64
MicroScan Pos MIC 40
MicroScan Neg Combo 96
MicroScan Neg Combo 94
MicroScan Neg Combo 97
MicroScan Neg Uriine Combo 95
MicroScan Neg MIC 61
MicroScan Neg Mutidrug Resistant MIC 2
MicroScan Neg Breakpoint Combo 53
MicroScan Neg MIC Panel Type 62
MicroScan Pos Combo Panel Type 48
MicroScan Neg Urine Combo Panel Type 98
MicroScan MSF Neg/Pos ID Type 2 Panel
MicroScan Pos Breakpoint Combo Panel Type 33
MicroScan Pos MIC Panel Type 28
MicroScan Neg BP Combo 1J(M)
MicroScan Neg Breakpoint Combo Panel Type 42
MicroScan Pos Breakpoint Combo Panel Type 28
MicroScan MSF Neg MIC Panel Type 2
MicroScan Dried Gram Positive MIC/Combo Panels - Tigecycline
MicroScan Dried Gram Positive MIC/Combo Panels - Linezolid
D23352 MicroScan LabPro V53 Panel Update 11 (US), Electronic
D33604 MicroScan LabPro V53 Data Delivery 07 (US), Electronic
D23354 MicroScan LabPro V53 Panel Update 11 DVD Kit (US)
MicroScan LabPro Data Management System
MicroScan LabPro Connect
MicroScan LabPro MBT
D23825, MicroScan LabPro Connect V53 System (US), Electronic
D23829 MicroScan LabPro Connect V53 System DVD Kit (US)
D23824 MicroScan LabPro V53 System (US), Electronic
D23828 MicroScan LabPro V53 System DVD Kit (US)
MicroScan Dried Gram Positive MIC/Combo Panels - Moxifloxacin
MicroScan Dried Gram Negative MIC/Combo Panels - Moxifloxacin
MicroScan Turbidity Meter
MicroScan Dried Gram Negative MIC/Combo Panels - Eravacycline
MicroScan ESBL Plus ESBL Confirmation - Ceftriaxone
MicroScan Dried Gram Positive MIC/Combo Panels - Ceftriaxone
MicroScan Dried Gram Negative MIC/Combo Panels - Ceftriaxone
MicroScan ESBL Plus ESBL Confirmation - Aztreonam
MicroScan Dried Gram Negative MIC/Combo Panels - Aztreonam
MicroScan ESBL Plus ESBL Confirmation - Ceftazidime
MicroScan MICroSTREP plus Panel - Clarithromycin
MicroScan Dried Gram Negative MIC/Combo Panels - Ertapenem
MicroScan Dried Gram Positive MIC/Combo Panels - Norfloxacin
MicroScan Dried Gram Negative MIC/Combo Panels - Norfloxacin
MicroScan Dried Gram Positive MIC/Combo Panels - Cefoxitin Screen Well
MicroScan Dried Gram-Negative MIC/Combo Panels - Meropenem
MicroScan Dried Gram Negative MIC/Combo Panels - Cefuroxime
VITEK REVEAL BC GN02-AST
MicroScan MICroSTREP plus Panels - Daptomycin
MicroScan Dried Gram Negative MIC/Combo Panels - Ceftazidime/Avibactam
MicroScan Dried Gram Positive MIC/Combo Panels - Daptomycin
MicroScan Rapid Pos ID Panel Type 2
MicroScan Pos ID Panel Type 3
MicroScan Dried Gram Positive Combo Panels
MicroScan Dried Gram Positive MIC/Combo Panels- Azithromycin
MicroScan Dried Gram Positive MIC/Combo Panels- Rifampin
MicroScan Dried Gram Negative MIC/Combo Panels - Ticarcillin/K. Clavulanate
MicroScan Dried Gram Negative ESBL Confirmation Panel - Imipenem
MicroScan Dried Gram Negative MIC/Combo Panels - Cefotetan
MicroScan Dried Gram Positive MIC/Combo Panels- Amoxicillin/K Clavulanate
MicroScan Dried Gram Negative ESBL Confirmation Panel - Cefotetan
MicroScan Dried Gram Negative MIC/Combo Panels - Imipenem
MicroScan Dried Gram Positive MIC/Combo Panels- Cefazolin
MicroScan Dried Gram Positive MIC/Combo Panels- Imipenem
MicroScan Dried Gram Positive MIC/Combo Panels- Cefuroxime
MicroScan Dried Gram Negative MIC/Combo Panels - Piperacillin/Tazobactam
MicroScan Dried Gram Positive MIC/Combo Panels - Inducible Clindamycin Test
MicroScan Rapid Yeast ID Panel
MicroScan Dried Gram-Positive MIC/Combo Panels with Ceftaroline
D03455 MicroScan LabPro v5 EU SMU Predictive Susceptibility (MR), Electronic
C79969 MicroScan LabPro V4.43/4.44 Panel Update-08 DVD Kit (MR)
D11977 MicroScan LabPro v50 Data Delivery-05, MR, Electronic
C82964 MicroScan LabPro v5 Maintenance Update 1 W/Panel Update 09 DVD Kit (MR)
D19723 MicroScan LabPro v50 Data Delivery-06 (FMR), Electronic
C66901 MicroScan LabPro V5 Panel Update - 07 DVD Kit (Japan)
D11478 MicroScan LabPro V4.45/V5 Data Delivery 4 (JP)
C66902 MicroScan LabPro V5 Update - 07 DVD System Kit (Japan)
C90683 MicroScan LabPro V5 Panel Update 10 (FMR), Electronic
C90384 MicroScan LabPro V5 Maintenance Update 1 W/Panel Update 09 (MR), Electronic
D12596 MicroScan LabPro V4_V5 Maintenance Update 05 (MR, FMR), Electronic
D12427 MicroScan LabPro V4_V5 Maintenance Update 05 (US), Electronic
D05946 MicroScan LabPro v50 Data Delivery-03, Electronic
D12429 MicroScan LabPro V4_V5 Maintenance Update 05 DVD Kit (US, FMR, MR)
MicroScan Dried Gram Negative MIC/Combo Panels - Levofloxacin
MicroScan RENOK Rehydrator / Inoculator System (PN B1018-14)
MicroScan RENOK Disposable R-Inoculator Sets
MicroScan RENOK Disposable D-Inoculator Sets
MicroScan MICroSTREP plus Panels - Levofloxacin
MicroScan Dried Gram Negative MIC/Combo Panels - Ceftolozane/Tazobactam
MicroScan Yeast Turbidity Standard 3ml
MicroScan 05N Sodium Hydroxide 250ml
MicroScan 05N Sodium Hydroxide 30ml
MicroScan Dried Gram-Negative MIC/Combo Panels - Ceftazidime
MicroScan Dried Gram Negative ESBL Confirmation Panel
MicroScan Dried Gram Negative MIC/Combo Panels - Amoxicillin/K Clavulanate
MicroScan Prompt Inoculation System-D
MicroScan Dried Gram Negative MIC/Combo Panels - Cefixime
MicroScan Dried Gram-Positive MIC/Combo Panels - Daptomycin
MicroScan Dried Gram Positive MIC/Combo Panels - Levofloxacin
MicroScan ESBL plus ESBL Confirmation Panel - Meropenem
MicroScan Dried Gram Negative MIC/Combo Panels - Meropenem
MicroScan ESBL plus ESBL Confirmation Panel - Ceftazidime
MicroScan ESBL plus ESBL Confirmation Panel - Ceftazidime / Clavulanic acid
MicroScan ESBL plus ESBL Confirmation Panel - Cefotaxime / Calvulanic acid
MicroScan ESBL plus ESBL Confirmation Panel - Cefotaxime
MicroScan Dried Gram Negative MIC/Combo Panels - Ciprofloxacin-S
MicroScan Dried Gram Positive MIC/Combo Panels - Piperacillin/ Tazobactam
MicroScan Xylene - 30ml
MicroScan Ehrlichs Reagent 30ml
MicroScan Dried Gram Positive MIC/Combo Panels - Gentamicin
MicroScan Dried Gram Positive MIC/Combo Panels - Streptomycin
MicroScan Cover Trays
MicroScan Seal Strip
MicroScan 96 Well Tray Lids
MicroScan Dried Gram Negative MIC/Combo Panels - Doripenem
MicroScan Dried Gram Negative MIC/Combo Panels - Meropenem/Vaborbactam
MicroScan Dried Gram Positive MIC/Combo Panels - Azithromycin
MicroScan Dried Gram Negative MIC/Combo Panels - Ciprofloxacin
MicroScan Dried Gram Positive MIC/Combo Panels - Ciprofloxacin
MicroScan MICroSTREP plus Panels - Clarithromycin
MicroScan Dried Gram Negative MIC/Combo Panels - Tigecycline
MicroScan 0.4% Saline with PLURONIC
MicroScan HNID Inoculum Broth
MicroScan Inoculum Water with PLURONIC
MicroScan 3ml Inoculum Saline
MicroScan Inoculum Water
Establishment Types
Manufacture Medical Device
Manufacture Device in the United States for Export Only
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device for Another Party (Contract Manufacturer)