FDA.report

Leica Biosystems CytoVision Microscope, Leica DM5000B

Primary DI
00849832010562
Brand
Leica Biosystems CytoVision Microscope, Leica DM5000B
Company
Leica Biosystems Richmond, Inc.
Model
23MIC5000
Device description
Leica Biosystems CytoVision Microscope, Leica DM5000B
Published
2016-09-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
JOYDEVICE, AUTOMATED CELL-LOCATING

Product Code Classifications

CodeDeviceSpecialtyClass
JOYDevice, Automated Cell-LocatingHematology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00849832010562PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00849832010562008498320105628498320105620849832010562

GMDN Terms

TermDefinition
Fluorescence light microscopeA magnification instrument in which light (typically ultraviolet) that has been absorbed by the specimen and re-emitted at a longer wavelength is observed (as visible light) so that the specimen is visible through the eyepiece. This device is typically used in the laboratory for histopathology and microbiology, commonly in conjunction with fluorescent dyes. Appropriate filters are used to select the correct wavelength of incoming beam to excite the fluorescent compound and eliminate the unwanted incident wavelength from the fluorescent light source (i.e., the specimen).

Device Sizes

TypeValueUnit
Device Size Text, specify0

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)5374669tech.support@Leicabiosystems.com

Regulatory Flags

DUNS number
082930884
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
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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