Salivary 17-OH Progesterone ELISA SLV-3140

GUDID 00404847431407

An enzyme immunoassay for the quantitative in vitro diagnostic measurement of active free 17-a-hydroxyprogesterone in saliva.

DRG Instruments Gesellschaft mit beschränkter Haftung

17-Hydroxyprogesterone IVD, kit, enzyme immunoassay (EIA) 17-Hydroxyprogesterone IVD, kit, enzyme immunoassay (EIA) 17-Hydroxyprogesterone IVD, kit, enzyme immunoassay (EIA) 17-Hydroxyprogesterone IVD, kit, enzyme immunoassay (EIA) 17-Hydroxyprogesterone IVD, kit, enzyme immunoassay (EIA) 17-Hydroxyprogesterone IVD, kit, enzyme immunoassay (EIA) 17-Hydroxyprogesterone IVD, kit, enzyme immunoassay (EIA) 17-Hydroxyprogesterone IVD, kit, enzyme immunoassay (EIA) 17-Hydroxyprogesterone IVD, kit, enzyme immunoassay (EIA) 17-Hydroxyprogesterone IVD, kit, enzyme immunoassay (EIA) 17-Hydroxyprogesterone IVD, kit, enzyme immunoassay (EIA) 17-Hydroxyprogesterone IVD, kit, enzyme immunoassay (EIA) 17-Hydroxyprogesterone IVD, kit, enzyme immunoassay (EIA) 17-Hydroxyprogesterone IVD, kit, enzyme immunoassay (EIA) 17-Hydroxyprogesterone IVD, kit, enzyme immunoassay (EIA) 17-Hydroxyprogesterone IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00404847431407
• NIH Device Record Key: 902e758f-ffb0-451e-8a73-177e08cb5948
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Salivary 17-OH Progesterone ELISA
• Version Model Number: SLV-3140
• Catalog Number: SLV-3140
• Company DUNS: 317134468
• Company Name: DRG Instruments Gesellschaft mit beschränkter Haftung
• 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: true
• 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: +1(973)564-7555
• Email: corp@drg-international.com
• Phone: +1(973)564-7555
• Email: corp@drg-international.com
• Phone: +1(973)564-7555
• Email: corp@drg-international.com
• Phone: +1(973)564-7555
• Email: corp@drg-international.com
• Phone: +1(973)564-7555
• Email: corp@drg-international.com
• Phone: +1(973)564-7555
• Email: corp@drg-international.com
• Phone: +1(973)564-7555
• Email: corp@drg-international.com
• Phone: +1(973)564-7555
• Email: corp@drg-international.com
• Phone: +1(973)564-7555
• Email: corp@drg-international.com
• Phone: +1(973)564-7555
• Email: corp@drg-international.com
• Phone: +1(973)564-7555
• Email: corp@drg-international.com
• Phone: +1(973)564-7555
• Email: corp@drg-international.com
• Phone: +1(973)564-7555
• Email: corp@drg-international.com
• Phone: +1(973)564-7555
• Email: corp@drg-international.com
• Phone: +1(973)564-7555
• Email: corp@drg-international.com
• Phone: +1(973)564-7555
• Email: corp@drg-international.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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00404847431407 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062534

FDA Product Code

• JLX: RADIOIMMUNOASSAY, 17-HYDROXYPROGESTERONE

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: 2021-06-15
• Device Publish Date: 2021-06-07

On-Brand Devices [Salivary 17-OH Progesterone ELISA]

• 00404847431407: An enzyme immunoassay for the quantitative in vitro diagnostic measurement of active free 17-a-h
• 04048474031409: An enzyme immunoassay for the quantitative in vitro diagnostic measurement of active free 17-a-h