Diagnostic Automation, Inc. SF2100

GUDID 00850049545501

Stat Fax 2100 Microplate Reader

Diagnostic Automation, Inc.

Microplate reader IVD, automated/semi-automated
Primary Device ID00850049545501
NIH Device Record Key49c5ec31-63f9-4015-a616-ef548c5bde6a
Commercial Distribution StatusIn Commercial Distribution
Brand NameDiagnostic Automation, Inc.
Version Model NumberDAI SF2100
Catalog NumberSF2100
Company DUNS878252071
Company NameDiagnostic Automation, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8185913030
EmailOneStep@rapidtest.com
Phone8185913030
EmailOneStep@rapidtest.com
Phone8185913030
EmailOneStep@rapidtest.com
Phone8185913030
EmailOneStep@rapidtest.com
Phone8185913030
EmailOneStep@rapidtest.com
Phone8185913030
EmailOneStep@rapidtest.com
Phone8185913030
EmailOneStep@rapidtest.com
Phone8185913030
EmailOneStep@rapidtest.com
Phone8185913030
EmailOneStep@rapidtest.com
Phone8185913030
EmailOneStep@rapidtest.com
Phone8185913030
EmailOneStep@rapidtest.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850049545501 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JJQColorimeter, Photometer, Spectrophotometer 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 Date2026-01-01
Device Publish Date2025-12-24

On-Brand Devices [Diagnostic Automation, Inc.]

00850054026392Stat Fax 2600 Microplate Washer
00850049545501Stat Fax 2100 Microplate Reader

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.