FDA.reportPublic FDA data

Sample Chambers w/ fast, white Cytopads, caps, pk48

Primary DI
03661540302671
Brand
Sample Chambers w/ fast, white Cytopads, caps, pk48
Company
ELITECHGROUP INC.
Model
SS-113
Catalog number
SS-113
Device description
Sample Chambers w/ fast, white Cytopads,caps, pk48
Published
2023-08-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
IFBCytocentrifuge

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IFBCytocentrifugePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03661540302671PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03661540302671036615403026713661540302671

GMDN Terms#

Term, Definition table
TermDefinition
Cytological centrifuge funnel IVDA small, tapered receptacle designed to be fitted into a cytological centrifuge/sample concentrator, and intended to contain and help concentrate clinical specimen suspension cells into thin-layer preparations by depositing them directly onto a microscope slide during centrifugation for subsequent examination. It is in the form of a conical-shaped plastic receptacle; some types have a slot for inserting a microscope slide. This is a single-use device.

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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03661540300301Excyte® ESR Non-Vacuum Tubes, CartonEX-50100EX-501002023-10-01
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03661540300240Excyte® ESR Non-Vacuum TubesEX-50100EX-501002023-10-01
03661540300257Excyte® ESR Vacuum TubesEX-50205EX-502052023-10-01
03661540300264Excyte® ESR Vacuum TubeEP-10605EP-106052023-10-01
03661540300271Excyte® ESR Vacuum TubeEP-10605-H1EP-10605-H12023-10-01
03661540304286Direct A1c Control Kit55136551362023-10-01

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