MedTest DX HCG Control Set HCG-CTL

GUDID 00817439020819

HCG Control Set, for In Vitro Diagnostic Use. HCG Control is an unassayed, stable, ready to use liquid, bi-level control for use with assays designed to quantitate HCG. It is intended for determining “Hook-Dose Effect” and the accuracy and precision of dilution protocols. Size: 4 x 2.5 mL.

Medtest Dx, Inc.

Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, control

• Primary Device ID: 00817439020819
• NIH Device Record Key: fb902fd1-5f0f-4b57-852d-89a7ec2a2545
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MedTest DX HCG Control Set
• Version Model Number: HCG-CTL
• Catalog Number: HCG-CTL
• Company DUNS: 070371210
• Company Name: Medtest Dx, 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: 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-445-9853
• Email: techservice@medtest.com
• Phone: 800-445-9853
• Email: techservice@medtest.com
• Phone: 800-445-9853
• Email: techservice@medtest.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and -20 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817439020819 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K921206

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-30

Devices Manufactured by Medtest Dx, Inc.

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• 00817439020024 - Direct Lipid Control L2: 2018-07-06 This product is intended for in-vitro use only, in the quality control of Direct HDL, Direct LDL, Lipoprotein (a), and Apolipopr
• 00817439020031 - Direct Lipid Control L3: 2018-07-06 This product is intended for in-vitro use only, in the quality control of Direct HDL, Direct LDL, Lipoprotein (a), and Apolipopr
• 00817439020093 - Albumin / BS480: 2018-07-06 For the quantitative determination of Albumin in serum using the Mindray BS-480 analyzer. In vitro diagnostic medical device. 8
• 00817439020109 - Albumin: 2018-07-06 For the quantitative in vitro determination of Albumin in serum and plasma on the Polychem 180 analyzer. 9 x 51 ml
• 00817439020116 - Albumin / BS200: 2018-07-06 For the quantitative determination of Albumin in serum using the Mindray BS-200 analyzer. 4 x 40 ml
• 00817439020123 - Alkaline Phos/ BS480: 2018-07-06 For the quantitative determination of Albumin in serum using the Mindray BS-480 analyzer. In vitro diagnostic medical device.
• 00817439020130 - ALP Reagent: 2018-07-06 For the quantitative in vitro determination of Alkaline Phosphatase (ALP) in serum and plasma. 6 x 51 ml, 6 x 14 ml