Salicylate Assay SK511-50

GUDID 00628063401123

SEKISUI DIAGNOSTICS, LLC

Salicylate IVD, kit, enzyme spectrophotometry
Primary Device ID00628063401123
NIH Device Record Key3672afc4-654c-4f12-b3ed-027c557f97d0
Commercial Distribution StatusIn Commercial Distribution
Brand NameSalicylate Assay
Version Model NumberSK511-50
Catalog NumberSK511-50
Company DUNS966812344
Company NameSEKISUI DIAGNOSTICS, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100628063401123 [Primary]

FDA Product Code

DKJCOLORIMETRY, SALICYLATE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-12-31
Device Publish Date2018-11-28

Devices Manufactured by SEKISUI DIAGNOSTICS, LLC

00628063401291 - Acetaminophen2023-05-16
00628063401307 - Acetaminophen Calibrator2023-05-16
00628063401314 - Alinity c Acetaminophen2023-05-16
00628063401321 - Alinity c Acetaminophen Calibrator2023-05-16
10742860100397 - OSOM ULTRA PLUS FLU A&B Test 2022-06-10
00628063401222 - DC-TROL LEVELS 1 & 22020-04-07
00628063400003 - Carbon Dioxide L3K2019-10-21
00628063400287 - CARBON DIOXIDE L3K Assay2019-10-21

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.