R Med Pregnancy Test Cassettes

GUDID B497542100C1001CA1

Human Chorionic Gonadotropin (HCG) test kit, over the counter, FDA product code LCX, individual tests in pouches; 50 tests per box. Market--physician

R MEDICAL SUPPLY INC

Total human chorionic gonadotropin (HCG) IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: B497542100C1001CA1
• NIH Device Record Key: cdb86510-5201-4b85-80f2-677ac327774c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: R Med Pregnancy Test Cassettes
• Version Model Number: C1001C-a
• Company DUNS: 788124873
• Company Name: R MEDICAL SUPPLY 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: true
• Device Combination Product: false
• Single Use: true
• 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: true

Customer Support Contacts

• Phone: 919-245-3600
• Email: sales@rmedicalsupply.com
• Phone: 919-245-3600
• Email: sales@rmedicalsupply.com
• Phone: 919-245-3600
• Email: sales@rmedicalsupply.com
• Phone: 919-245-3600
• Email: sales@rmedicalsupply.com
• Phone: 919-245-3600
• Email: sales@rmedicalsupply.com
• Phone: 919-245-3600
• Email: sales@rmedicalsupply.com
• Phone: 919-245-3600
• Email: sales@rmedicalsupply.com
• Phone: 919-245-3600
• Email: sales@rmedicalsupply.com
• Phone: 919-245-3600
• Email: sales@rmedicalsupply.com
• Phone: 919-245-3600
• Email: sales@rmedicalsupply.com
• Phone: 919-245-3600
• Email: sales@rmedicalsupply.com
• Phone: 919-245-3600
• Email: sales@rmedicalsupply.com
• Phone: 919-245-3600
• Email: sales@rmedicalsupply.com
• Phone: 919-245-3600
• Email: sales@rmedicalsupply.com
• Phone: 919-245-3600
• Email: sales@rmedicalsupply.com
• Phone: 919-245-3600
• Email: sales@rmedicalsupply.com
• Phone: 919-245-3600
• Email: sales@rmedicalsupply.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B49754210021001CA11 [Package]; Package: [50 Units]; In Commercial Distribution
HIBCC	B497542100C1001CA1 [Primary]

FDA Product Code

• LCX: Kit, Test, Pregnancy, Hcg, Over The Counter

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-01-13

Devices Manufactured by R MEDICAL SUPPLY INC

• B49746721COLLSE0 - R Med Collection Set: 2018-03-29 Vacuum Tubing with handle and adapter; single use, sterile, flexible, 6' long, 1/2" outer diameter.
• B497542100C1001CA1 - R Med Pregnancy Test Cassettes: 2018-03-29Human Chorionic Gonadotropin (HCG) test kit, over the counter, FDA product code LCX, individual tests in pouches; 50 tests per box. Market--physician
• B497542100C1001CA1 - R Med Pregnancy Test Cassettes: 2018-03-29 Human Chorionic Gonadotropin (HCG) test kit, over the counter, FDA product code LCX, individual tests in pouches; 50 tests per b
• B497542100C1001S1 - R Med Pregnancy Test Strip: 2018-03-29 Human Chorionic Gonadotropin (HCG) test kit, over the counter, FDA product code LCX, individual test strips in pouches; 50 tests