FDA.reportPublic FDA data

ASFA® SPOTTER

Primary DI
08800066300111
Brand
ASFA® SPOTTER
Company
MBD CO., Ltd.
Model
MBD-SP-ST006
Device description
ASFA SPOTTER: It is used to precisely and accurately dispense biological samples such as cells, drugs, and viruses into well plates and microchips.
Published
2023-11-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JTCDevice, Microtiter Diluting/Dispensing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JTCDevice, Microtiter Diluting/DispensingMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800066300111PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800066300111088000663001118800066300111

GMDN Terms#

Term, Definition table
TermDefinition
Microbial specimen inoculation/streaking/colony-picking instrument IVDAn electrically-powered instrument intended for the pre-analytical preparation of microbial samples (e.g., cultures, suspensions, MALDI-TOF targets/slides) from a clinical specimen and/or culture isolate. Its functionality includes: 1) automated/semi-automated transfer of the clinical specimen (e.g., by aspiration or inoculating loop), inoculation into/onto culture dishes/tubes/slides, and streaking of culture dishes (e.g., using magnetic beads, inoculation loops or spreaders); and/or 2) automated microbial colony picking for the preparation of samples for subsequent analytical procedures. It may also feature processing capabilities such as barcoding, storage, and/or sorting.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth600Millimeter
Height618Millimeter
Width1045Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+82 318889381Info@mbdbiotech.com

Regulatory Flags#

DUNS number
690430688
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800066300104ASFA® SCANNERMBD-SC-ST0052023-11-21
08800066300005ASFA SCANNERMBD-SC4C-S2020-01-29
08800066300012ASFA SPOTTERMBD-MA-ST2020-01-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
58059796363919Slide Prep Evo™COPAN WASP SRLJTC2026-02-26
58059796363926Pipettor ModuleCOPAN WASP SRLJTC2026-02-26
00382904469733BD Kiestra™ InoqulABD Kiestra B.V.JTC2025-02-18
58059796363506WASP®COPAN WASP SRLJTC2024-11-21
00810044208047Caplugs/EvergreenCAPlugsJTC2024-05-31
00810044208054Caplugs/EvergreenCAPlugsJTC2024-05-31
00810044208061Caplugs/EvergreenCAPlugsJTC2024-05-31
00810044208078Caplugs/EvergreenCAPlugsJTC2024-05-31
00810044208252Caplugs/EvergreenCAPlugsJTC2024-05-31
00810044208269Caplugs/EvergreenCAPlugsJTC2024-05-31
00810044208276Caplugs/EvergreenCAPlugsJTC2024-05-31
00810044208283Caplugs/EvergreenCAPlugsJTC2024-05-31
06936895300083BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JTC2023-07-05
06936895300090BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JTC2023-07-05
06936895300106BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JTC2023-07-05
06936895300113BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JTC2023-07-05
06936895300076BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JTC2023-07-04
03610520010877BIO RADBIO-RAD LABORATORIES, INC.JTC2023-02-03
00848838022333REMELREMEL, INC.JTC2023-01-03
15099590655532MicroScanBeckman Coulter, Inc.JTC2022-12-13
15099590655549MicroScanBeckman Coulter, Inc.JTC2022-12-13
15099590655556MicroScanBeckman Coulter, Inc.JTC2022-12-13
15099590702052MicroScanBeckman Coulter, Inc.JTC2022-12-13
15099590658236MicroScanBeckman Coulter, Inc.JTC2022-11-15
00894175000497Diagnostic AutomationDiagnostic Automation, Inc.JTC2021-09-16
58050148211414WASP®COPAN WASP SRLJTC2021-04-27
58050148218277Pipettor ModuleCOPAN WASP SRLJTC2021-04-27
58050148218970Slide Prep Evo™COPAN WASP SRLJTC2021-04-27
58052870813669Collaborative StationCOPAN WASP SRLJTC2021-04-27
08800066300012ASFA SPOTTERMBD CO., Ltd.JTC2020-01-29