Bolt (CLIA) 00500-CLR

GUDID B35000500CLR0

Bolt EIA-CLIA (refurbished)

Gold Standard Diagnostics Corporation

Chemiluminescent immunoassay analyser IVD
Primary Device IDB35000500CLR0
NIH Device Record Keyabf5f627-40e3-462a-9e5f-45aaba729985
Commercial Distribution StatusIn Commercial Distribution
Brand NameBolt (CLIA)
Version Model Number00500-CLR
Catalog Number00500-CLR
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
HIBCCB35000500CLR0 [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 Date2023-11-08
Device Publish Date2023-10-31

On-Brand Devices [Bolt (CLIA)]

B35000500CL0Bolt EIA-CLIA
B35000500CLR0Bolt EIA-CLIA (refurbished)

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