Pregnancy-Skreen

GUDID 00810042683174

hCG Low Positive/Negative Urine 2x5mL Kitbox

BIOCHEMICAL DIAGNOSTICS INC

Human chorionic gonadotropin beta-core fragment (beta-HCG) IVD, control Human chorionic gonadotropin beta-core fragment (beta-HCG) IVD, control Human chorionic gonadotropin beta-core fragment (beta-HCG) IVD, control Human chorionic gonadotropin beta-core fragment (beta-HCG) IVD, control Human chorionic gonadotropin beta-core fragment (beta-HCG) IVD, control Human chorionic gonadotropin beta-core fragment (beta-HCG) IVD, control Human chorionic gonadotropin beta-core fragment (beta-HCG) IVD, control Human chorionic gonadotropin beta-core fragment (beta-HCG) IVD, control Human chorionic gonadotropin beta-core fragment (beta-HCG) IVD, control Human chorionic gonadotropin beta-core fragment IVD, control Human chorionic gonadotropin beta-core fragment IVD, control Human chorionic gonadotropin beta-core fragment IVD, control Human chorionic gonadotropin beta-core fragment IVD, control Human chorionic gonadotropin beta-core fragment IVD, control Human chorionic gonadotropin beta-core fragment IVD, control Human chorionic gonadotropin beta-core fragment IVD, control Human chorionic gonadotropin beta-core fragment IVD, control Human chorionic gonadotropin beta-core fragment IVD, control Human chorionic gonadotropin beta-core fragment IVD, control Human chorionic gonadotropin beta-core fragment IVD, control Human chorionic gonadotropin beta-core fragment IVD, control Human chorionic gonadotropin beta-core fragment IVD, control Human chorionic gonadotropin beta-core fragment IVD, control

• Primary Device ID: 00810042683174
• NIH Device Record Key: 0bac29b3-81dc-4b13-9925-caa48fd0ca3c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pregnancy-Skreen
• Version Model Number: 18003155
• Company DUNS: 028007698
• Company Name: BIOCHEMICAL DIAGNOSTICS INC
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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

Customer Support Contacts

• Phone: 631-595-9200
• Email: support@biochemicaldiagnostics.com
• Phone: 631-595-9200
• Email: support@biochemicaldiagnostics.com
• Phone: 631-595-9200
• Email: support@biochemicaldiagnostics.com
• Phone: 631-595-9200
• Email: support@biochemicaldiagnostics.com
• Phone: 631-595-9200
• Email: support@biochemicaldiagnostics.com
• Phone: 631-595-9200
• Email: support@biochemicaldiagnostics.com
• Phone: 631-595-9200
• Email: support@biochemicaldiagnostics.com
• Phone: 631-595-9200
• Email: support@biochemicaldiagnostics.com
• Phone: 631-595-9200
• Email: support@biochemicaldiagnostics.com
• Phone: 631-595-9200
• Email: support@biochemicaldiagnostics.com
• Phone: 631-595-9200
• Email: support@biochemicaldiagnostics.com
• Phone: 631-595-9200
• Email: support@biochemicaldiagnostics.com
• Phone: 631-595-9200
• Email: support@biochemicaldiagnostics.com
• Phone: 631-595-9200
• Email: support@biochemicaldiagnostics.com
• Phone: 631-595-9200
• Email: support@biochemicaldiagnostics.com
• Phone: 631-595-9200
• Email: support@biochemicaldiagnostics.com
• Phone: 631-595-9200
• Email: support@biochemicaldiagnostics.com
• Phone: 631-595-9200
• Email: support@biochemicaldiagnostics.com
• Phone: 631-595-9200
• Email: support@biochemicaldiagnostics.com
• Phone: 631-595-9200
• Email: support@biochemicaldiagnostics.com
• Phone: 631-595-9200
• Email: support@biochemicaldiagnostics.com
• Phone: 631-595-9200
• Email: support@biochemicaldiagnostics.com
• Phone: 631-595-9200
• Email: support@biochemicaldiagnostics.com

Operating and Storage Conditions

• 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
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00810042683174 [Primary]

FDA Product Code

• JJX: Single (Specified) Analyte Controls (Assayed And Unassayed)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-08-30
• Device Publish Date: 2021-08-20

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