JANUS G3 NGS Express

GUDID 00812589020603

JANUS G3 NGS Express, IVD

Caliper Life Sciences, Inc.

Pipetting system IVD
Primary Device ID00812589020603
NIH Device Record Key306fe13d-adeb-41c2-ad89-c6e94b88f0b3
Commercial Distribution StatusIn Commercial Distribution
Brand NameJANUS G3 NGS Express
Version Model NumberCJS4NGS
Company DUNS933210197
Company NameCaliper Life Sciences, Inc.
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 Numberfalse
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
GS100812589020603 [Primary]

FDA Product Code

JQWStation, Pipetting And Diluting, 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 Date2022-01-28
Device Publish Date2022-01-20

Devices Manufactured by Caliper Life Sciences, Inc.

00812589020979 - Fontus2024-07-10 Fontus NGS LH, 8-96, IVD
00812589021051 - Fontus2024-07-10 Fontus NGS LH, 8-384, IVD
00812589021068 - Fontus2024-07-10 Fontus LH, Standard, 8-96, IVD
00812589021075 - Fontus2024-07-10 Fontus LH, Expanded, 8-96, IVD
00812589021082 - Fontus2024-07-10 Fontus LH, Standard, 8-384, IVD
00812589021099 - Fontus2024-07-10 Fontus LH, Expanded, 8-384, IVD
00812589021129 - Fontus2024-07-10 Fontus LH, Expanded, 8, IVD
00812589021136 - Fontus2024-07-10 Fontus LH, Standard, 8, IVD

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