Cyanmethemoglobin Standard (20 gm/dL @ 1:251 DILUTION)

Basic Information

• Brand Name: Cyanmethemoglobin Standard (20 gm/dL @ 1:251 DILUTION)
• Primary DI: 00657498001158
• Version / Model: 0325-006
• Catalog Number: 0325-006
• Company Name: STANBIO LABORATORY, L.P.
• Labeler DUNS: 045361136
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: fbf75505-0ab8-4074-aee4-164a1e757b3e
• Distribution End Date: 2017-08-24

Device Description

For the Quantitative Colorimetric Determination of Hemoglobin in Whole Blood.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GJZ	Cyanomethemoglobin Reagent And Standard Solution	Hematology	864.7500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32430	Cyanomethemoglobin kit	A test system consisting of one or multiple reagents and other items intended to measure the concentration of cyanomethemoglobin in a biological sample. Measurements are used to determine the concentration of haemoglobin for the detection of anaemia.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00657498001158	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius