FDA.reportPublic FDA data

LabChoice Microcentrifuge Tubes, Polypropylene, 0.5mL, Non-Sterile

Primary DI
00810180840996
Brand
LabChoice Microcentrifuge Tubes, Polypropylene, 0.5mL, Non-Sterile
Company
Dynarex Corporation
Model
42120
Device description
Features: Snap cap, graduation marks, Frosted writing area, RCF 15, 000xg
Published
2025-02-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
JQCCentrifuges (Micro, Ultra, Refrigerated) For Clinical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JQCCentrifuges (Micro, Ultra, Refrigerated) For Clinical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840117330283PackageGS110In Commercial Distribution
00840117337282PrimaryGS10
00810180840996Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117330283008401173302838401173302830840117330283
00840117337282008401173372828401173372820840117337282
00810180840996008101808409968101808409960810180840996

GMDN Terms#

Term, Definition table
TermDefinition
Centrifuge tube IVDA tube intended to be used in the laboratory to contain a clinical specimen, reagent, or other material associated with in vitro diagnostic testing, for separation by centrifugation. It is designed to be placed in a centrifuge rotor for the procedure; it may also be placed in a rack for short-term storage of its contents. It is typically transparent to facilitate observation of its contents, frequently includes a cap (e.g., screw or press-fit), and may have graduations along the side. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008124539
Device count
1000
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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