Histoplasma DxSelect™

GUDID 20816101022230

Histoplasma capsulatum antigen IVD, kit, enzyme immunoassay (EIA) Histoplasma capsulatum antigen IVD, kit, enzyme immunoassay (EIA)

Primary Device ID	20816101022230
NIH Device Record Key	2afa100d-420f-49fd-8586-e374debac0d5
Commercial Distribution Status	In Commercial Distribution
Brand Name	Histoplasma DxSelect™
Version Model Number	EL1700
Company DUNS	080271715
Company Name	DIASORIN MOLECULAR LLC
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	false
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

Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius

Device Issuing Agency	Device ID
GS1	20816101022230 [Primary]

MIZ	Enzyme Linked Immunoabsorbent Assay, Histoplasma Capsulatum

Steralize Prior To Use	false
Device Is Sterile	false

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