Nano-CheckTM AMI 2 in 1 CD202P

GUDID 00895160002120

Multiple cardiac marker IVD, reagent

Primary Device ID	00895160002120
NIH Device Record Key	bc25f1a5-c9a1-4da3-937e-00f60f70695e
Commercial Distribution Discontinuation	2022-12-31
Commercial Distribution Status	Not in Commercial Distribution
Brand Name	Nano-CheckTM AMI 2 in 1
Version Model Number	CD202P
Catalog Number	CD202P
Company DUNS	126544316
Company Name	NANO-DITECH CORPORATION
Device Count	20
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	false
OTC Over-The-Counter	false

Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius

Device Issuing Agency	Device ID
GS1	00895160002120 [Primary]
GS1	10895160002127 [Unit of Use]

DDR	Myoglobin, Antigen, Antiserum, Control

Steralize Prior To Use	false
Device Is Sterile	false

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