Sedi
Globe Scientific - 3471V
Device Description
An open-ended glass or plastic tube, or other dedicated vessel, intended to be used alone or in combination with other IVDs (e.g., ESR analyser, scaled ruler) for the quantitative determination of the erythrocyte sedimentation rate (ESR) of a whole blood clinical specimen. This is a single-use device.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: JPH
Device Name: Test, Erythrocyte Sedimentation Rate
Device Class: 1
Physical State: N/A
Definition: N/A
Submission Type ID: 4
Review Panel: HE
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 864.6700
Third Party Flag: N
Medical Specialty: HE
Device IdentifiersDevice Id: 00840095624565
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 00840095624572
Package Quantity: 800
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: case
Device Id: 00840095624572
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A
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