FDA.reportPublic FDA data

LabChoice Reagent Reservoirs, 25mL, Non-Sterile,White

Primary DI
00840117331389
Brand
LabChoice Reagent Reservoirs, 25mL, Non-Sterile,White
Company
Dynarex Corporation
Model
41121
Published
2025-03-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
00840117329720PackageGS15In Commercial Distribution
00840117331389PrimaryGS10
00810180841405Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117329720008401173297208401173297200840117329720
00840117331389008401173313898401173313890840117331389
00810180841405008101808414058101808414050810180841405

GMDN Terms#

Term, Definition table
TermDefinition
Assay container IVD, single-useA reservoir (e.g., bottle, tube, cup) intended to be used to contain volumes of reagent, buffers, biological specimens, or other materials in preparation for in vitro diagnostic testing procedures performed in the laboratory. It is typically made of plastic or glass and may be used on the benchtop for manual procedures, or on-board automated liquid handling instruments or analysers. This is a single-use device.

Regulatory Flags#

DUNS number
008124539
Device count
100
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

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00616784435213Gait Belt, Natural Colors, Metal Buckle, 60" x 2"43522021-09-01
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00616784351612Heavy Duty Fitted Cot Sheet, White, 30" x 73"35162021-09-01
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