PCA(RS)48 Test(L) 4048L

GUDID 00813545022600

Parietal cell antibody IVD, kit, fluorescent immunoassay

Primary Device ID	00813545022600
NIH Device Record Key	1fcf03fa-43b3-4599-9ece-1b1f5a253234
Commercial Distribution Status	In Commercial Distribution
Brand Name	PCA(RS)48 Test(L)
Version Model Number	4048L
Catalog Number	4048L
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	00813545022600 [Primary]

DBJ	Antiparietal Antibody, Indirect Immunofluorescent, Antigen, Control

Steralize Prior To Use	false
Device Is Sterile	false

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