Alinity c Acetaminophen

GUDID 00628063401314

SEKISUI DIAGNOSTICS, LLC

Acetaminophen IVD, kit, enzyme spectrophotometry
Primary Device ID00628063401314
NIH Device Record Keye1d7a13e-2187-4370-bc3e-aad3df12af47
Commercial Distribution StatusIn Commercial Distribution
Brand NameAlinity c Acetaminophen
Version Model Number07P5420
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100628063401314 [Primary]

FDA Product Code

LDPColorimetry, Acetaminophen

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-05-16
Device Publish Date2023-05-08

Devices Manufactured by SEKISUI DIAGNOSTICS, LLC

00628063401291 - Acetaminophen2023-05-16
00628063401307 - Acetaminophen Calibrator2023-05-16
00628063401314 - Alinity c Acetaminophen2023-05-16
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

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