ThunderBolt EIA (CLIA) 00300CL

GUDID B35000300CL0

ThunderBolt EIA-CLIA

Gold Standard Diagnostics Corporation

Enzyme immunoassay (EIA) analyser IVD
Primary Device IDB35000300CL0
NIH Device Record Key971afbb0-f130-4587-b913-1537cb83dd40
Commercial Distribution StatusIn Commercial Distribution
Brand NameThunderBolt EIA (CLIA)
Version Model Number00300-CL
Catalog Number00300CL
Company DUNS790524891
Company NameGold Standard Diagnostics Corporation
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB35000300CL0 [Primary]

FDA Product Code

JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-10-03
Device Publish Date2022-09-24

On-Brand Devices [ThunderBolt EIA (CLIA)]

B35000300CL0ThunderBolt EIA-CLIA
B35000300CLR0ThunderBolt EIA-CLIA (refurbished)

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