FDA.reportPublic FDA data

Microscope slides, 1/2G, coated, for Cytopro

Primary DI
03661540302725
Brand
Microscope slides, 1/2G, coated, for Cytopro
Company
ELITECHGROUP INC.
Model
SS-118
Catalog number
SS-118
Device description
Microscope slides, 1/2G, coated, for Cytopro. Slides are used to collect the material centrifuged out of the solutions contained in the sample chambers. Slides are designed specifically for single, double, or magnum chambers and come in coated and uncoated versions for each.
Published
2023-08-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03661540302725PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03661540302725036615403027253661540302725

GMDN Terms#

Term, Definition table
TermDefinition
Cytological centrifuge IVDAn electrically-powered device intended to be used in a clinical laboratory setting to separate the cellular components of suspensions in a clinical specimen through centrifugal force for subsequent cytological analysis. It is typically a compact unit with an electric motor, a vertical shaft, and a special horizontal rotor attached that enables cells to be separated from a liquid suspension and deposited directly onto a microscope slide for microscopic examination.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 (800) 453-2725info@elitechgroup.com

Regulatory Flags#

DUNS number
052423787
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

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