ACL TOP 770 LAS 00000280037

GUDID 00195226000535

Coagulation analyser IVD, laboratory

Primary Device ID	00195226000535
NIH Device Record Key	39a260d7-d56e-4f18-8cd8-5ac3c207f64b
Commercial Distribution Status	In Commercial Distribution
Brand Name	ACL TOP 770 LAS
Version Model Number	00000280037
Catalog Number	00000280037
Company DUNS	557223252
Company Name	INSTRUMENTATION LABORATORY COMPANY
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00195226000535 [Primary]

GKP	Instrument, Coagulation, Automated

Steralize Prior To Use	false
Device Is Sterile	false

08430793242998 - HEMOSIL RIVAROXABAN CONTROLS	2024-07-30 1. Rivaroxaban Low Control (Cat. No. 0020015510): 5 x 1mL vials 2. Rivaroxaban High Control (Cat. No. 0020015520): 5 x 1mL vial
08430793243001 - HEMOSIL RIVAROXABAN CALIBRATORS	2024-07-30 1. Rivaroxaban Calibrator 1 (Cat. No. 0020015410): 5 x 1mL vials 2. Rivaroxaban Calibrator 2 (Cat. No. 0020015420) : 5 x 1mL vi
00195226001129 - HemosIL Chromogenic Factor IX	2024-07-17 HemosIL Chromogenic Factor IX
00195226000528 - ACL TOP 770	2024-05-23 ACL TOP 770
00195226000535 - ACL TOP 770 LAS	2024-05-23ACL TOP 770 LAS
00195226000535 - ACL TOP 770 LAS	2024-05-23 ACL TOP 770 LAS
00195226000542 - ACL TOP 770s	2024-05-23 ACL TOP 770s
00195226000559 - ACL TOP 570	2024-05-23 ACL TOP 570
00195226000566 - ACL TOP 370	2024-05-23 ACL TOP 370