ORTHOTM Sera Anti-D (IAT) Blood Grouping Reagent

Basic Information

• Brand Name: ORTHOTM Sera Anti-D (IAT) Blood Grouping Reagent
• Primary DI: 10758750013067
• Version / Model: 6904553
• Company Name: ALBA BIOSCIENCE LIMITED
• Labeler DUNS: 516536641
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-08-29
• Public Version: 4
• Public Version Date: 2022-03-31
• Public Version Status: Update
• Public Device Record Key: 0f5fa534-2a50-40d5-b910-89acd7d62a50

Device Description

The Anti-D (IAT) reagent (Anti-RH1) is for the qualitative in vitro detection of human RhD positive red blood cells by the indirect antiglobulin test.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• 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

GMDN Terms

Code	Name	Definition	Implantable	Status
52741	Weak anti-D IVD, control	A material containing weak antibodies directed towards Rh(D) [RH001] red blood cell antigens from the Rhesus system, which is used to verify the performance of an assay intended to be used in testing a clinical specimen for red blood cell antigens, using an antiglobulin technique.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10758750013067	GS1

Customer Contacts

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

Storage Conditions

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