FDA.report

Automate 2500 Family

Primary DI
15099590364465
Brand
Automate 2500 Family
Company
Beckman Coulter, Inc.
Model
AutoMate 1200
Catalog number
ODL25120
Device description
AutoMate1200 – Standard Sorter
Published
2016-08-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
JQPCalculator/Data Processing Module, For Clinical Use

Product Code Classifications

CodeDeviceSpecialtyClass
JQPCalculator/Data Processing Module, For Clinical UseClinical Chemistry1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
15099590364465PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1509959036446515099590364465

GMDN Terms

TermDefinition
Specimen processing instrument IVD, automatedA mains electricity (AC-powered) instrument or platform intended to be used for the automated pre-analytical preparation of a clinical specimen (excluding specimens for microbial culture), which may include the sampling, diluting, and/or aliquoting of clinical specimens and/or any post-analytical processing required, including labelling, storage and/or location data. The device operates with minimal technician involvement and automation of all procedural steps.

Storage And Handling

TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature-4 Degrees Fahrenheit140 Degrees Fahrenheit
Special Storage Condition, Specify00Altitude Must not exceed 6,562 ft
Storage Environment Humidity40 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature64 Degrees Fahrenheit89 Degrees Fahrenheit

Sterilization Methods

Method

Contacts

PhoneEmail
(800) 854-3633xx@xx.com

Regulatory Flags

DUNS number
008254708
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00810142373500SoftBiochemistrySCC SOFT COMPUTERJQP2026-02-04
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00810142373548SoftHLASCC SOFT COMPUTERJQP2026-02-04
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