FDA.report

Globe Scientific

Primary DI
00840095600019
Brand
Globe Scientific
Company
GLOBE SCIENTIFIC INC.
Model
101020
Device description
Scintillation Vial, 6.5mL, PE, with Attached White Screw Cap
Published
2019-12-18
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

Related Records

Product Codes

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

Product Code Classifications

CodeDeviceSpecialtyClass
LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical UseClinical Chemistry1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840095600019PrimaryGS10
00840095608541Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840095600019008400956000198400956000190840095600019
00840095608541008400956085418400956085410840095608541

GMDN Terms

TermDefinition
Liquid scintillation counterA precise radiation counting instrument designed to measure radioactivity emanating from a radioactive tracer on labelled samples. Primarily used to count beta particles, the radioactive sample is dissolved or suspended in an organic scintillation fluid where the emission of a beta particle causes the liquid to emit light which is detected and counted. The instrument typically consist of vials containing the radioactive samples and scintillation fluid, and electronics. It is typically applied as a detector for radioimmunoassay or immuno-radiometric assay for clinical use.

Sterilization Methods

Method

Regulatory Flags

DUNS number
106793995
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
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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