HYDROXYPROGESTERONE LEVEL 1 HPROG 1 S F FUMC

GUDID B800HPROG1SFFUMC5

HYDROXYPROGESTERONE LEVEL 1

UTAK LABORATORIES, INC.

Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control Multiple-type clinical chemistry analyte profile IVD, control

• Primary Device ID: B800HPROG1SFFUMC5
• NIH Device Record Key: 9dadb537-37bc-4aa8-9271-d389334745fa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HYDROXYPROGESTERONE LEVEL 1
• Version Model Number: HPROG 1 S F FUMC
• Catalog Number: HPROG 1 S F FUMC
• Company DUNS: 092519016
• Company Name: UTAK LABORATORIES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: 1-888-882-5522
• Email: WELOVECONTROL@UTAK.COM
• Phone: 1-888-882-5522
• Email: WELOVECONTROL@UTAK.COM
• Phone: 1-888-882-5522
• Email: WELOVECONTROL@UTAK.COM
• Phone: 1-888-882-5522
• Email: WELOVECONTROL@UTAK.COM
• Phone: 1-888-882-5522
• Email: WELOVECONTROL@UTAK.COM
• Phone: 1-888-882-5522
• Email: WELOVECONTROL@UTAK.COM
• Phone: 1-888-882-5522
• Email: WELOVECONTROL@UTAK.COM
• Phone: 1-888-882-5522
• Email: WELOVECONTROL@UTAK.COM
• Phone: 1-888-882-5522
• Email: WELOVECONTROL@UTAK.COM
• Phone: 1-888-882-5522
• Email: WELOVECONTROL@UTAK.COM
• Phone: 1-888-882-5522
• Email: WELOVECONTROL@UTAK.COM

Device Dimensions

• Total Volume: 2 Milliliter
• Total Volume: 2 Milliliter
• Total Volume: 2 Milliliter
• Total Volume: 2 Milliliter
• Total Volume: 2 Milliliter
• Total Volume: 2 Milliliter
• Total Volume: 2 Milliliter
• Total Volume: 2 Milliliter
• Total Volume: 2 Milliliter
• Total Volume: 2 Milliliter
• Total Volume: 2 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -10 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B800HPROG1SFFUMC0 [Primary]
HIBCC	B800HPROG1SFFUMC5 [Package]; Contains: B800HPROG1SFFUMC0; Package: box [25 Units]; In Commercial Distribution

FDA Product Code

• LAS: Drug Specific Control Materials

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: 2024-05-07
• Device Publish Date: 2024-04-29

Devices Manufactured by UTAK LABORATORIES, INC.

• B800SELEN100SBP0 - SELENIUM 100 UG/L: 2024-05-15 SELENIUM 100 UG/L
• B800SELEN200SBP5 - SELENIUM 200 UG/L: 2024-05-15 SELENIUM 200 UG/L
• B80088121CDFF10FS5 - CERTIFIED DRUG FREE URINE: 2024-05-14 CERTIFIED DRUG FREE URINE
• B8007AMINOHIGHUPM5 - 7-AMINOCLONAZEPAM HIGH: 2024-05-13 7-AMINOCLONAZEPAM LOW
• B8007AMINOLOWUPM5 - 7-AMINOCLONAZEPAM LOW: 2024-05-13 7-AMINOCLONAZEPAM LOW
• B800LAMO1V3SUCH5 - LAMOTRIGINE PLUS LEVEL 1: 2024-05-10 LAMOTRIGINE PLUS LEVEL 1
• B800LAMO2V3SUCH5 - LAMOTRIGINE PLUS LEVEL 2: 2024-05-10 LAMOTRIGINE PLUS LEVEL 2
• B800LAMO3V3SUCH5 - LAMOTRIGINE PLUS LEVEL 3: 2024-05-10 LAMOTRIGINE PLUS LEVEL 3