SSA (Ro) ELISA EIA-2782

GUDID 04048474027822

Multiple extractable nuclear antigen (ENA) IVD, kit, enzyme immunoassay (EIA)

Primary Device ID	04048474027822
NIH Device Record Key	5c3f8e67-47c0-4444-8291-12d744a7b924
Commercial Distribution Status	In Commercial Distribution
Brand Name	SSA (Ro) ELISA
Version Model Number	EIA-2782
Catalog Number	EIA-2782
Company DUNS	317134468
Company Name	DRG Instruments Gesellschaft mit beschränkter Haftung
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	true
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
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
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
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	04048474027822 [Primary]

LJM	Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls

Steralize Prior To Use	false
Device Is Sterile	false

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