CMA(RH) 48 Test(L) 5448RL

GUDID 00813545022860

Striated muscle antibody IVD, kit, fluorescent immunoassay

Primary Device ID	00813545022860
NIH Device Record Key	77b97ef1-ba2f-4e00-b4fb-dd97da0450af
Commercial Distribution Status	In Commercial Distribution
Brand Name	CMA(RH) 48 Test(L)
Version Model Number	5448RL
Catalog Number	5448RL
Company DUNS	155424708
Company Name	SCIMEDX CORPORATION
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	true
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00813545022860 [Primary]

DBL	Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control

Steralize Prior To Use	false
Device Is Sterile	false

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