Pregnancy-Skreen

Basic Information

• Brand Name: Pregnancy-Skreen
• Primary DI: 00810042683174
• Version / Model: 18003155
• Company Name: BIOCHEMICAL DIAGNOSTICS INC
• Labeler DUNS: 028007698
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-08-20
• Public Version: 2
• Public Version Date: 2022-08-30
• Public Version Status: Update
• Public Device Record Key: 0bac29b3-81dc-4b13-9925-caa48fd0ca3c

Device Description

hCG Low Positive/Negative Urine 2x5mL Kitbox

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

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	862.1660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
42729	Human chorionic gonadotropin beta-core fragment IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of human chorionic gonadotropin beta-core fragment, a metabolite of human chorionic gonadotropin beta-subunit (beta-HCG), in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810042683174	GS1

Customer Contacts

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

Storage Conditions

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