VFE VE-98

GUDID 08600000686048

EIA-VON WILLEBR.

Ramco Laboratories, Inc.

Coagulation factor VIII-associated antigen IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 08600000686048
• NIH Device Record Key: f15f14a2-6149-4452-ae91-f76b6cc8145f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VFE
• Version Model Number: VE-98
• Catalog Number: VE-98
• Company DUNS: 082013897
• Company Name: Ramco Laboratories, 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: true
• 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(281)313-1200
• Email: ramcolab@aol.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08600000686048 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K983107

FDA Product Code

• GGP: TEST, QUALITATIVE AND QUANTITATIVE FACTOR DEFICIENCY

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: 2019-04-03
• Device Publish Date: 2019-03-26

Devices Manufactured by Ramco Laboratories, Inc.

• 08600000686031 - TfR: 2019-04-03 ELISA- TfR
• 08600000686048 - VFE: 2019-04-03EIA-VON WILLEBR.
• 08600000686048 - VFE: 2019-04-03 EIA-VON WILLEBR.
• 18600000686021 - Cand-Tec: 2019-04-03 Candida Detection
• 28600000686028 - Cand-Tec: 2019-04-03 Candida Detection
• 78600000686023 - Cand-Tec: 2019-04-03 Candida Detection
• 08600000686017 - Spectro Ferritin MT: 2019-04-01 ELISA-ferritin
• 08600000686024 - Cand-Tec: 2019-04-01 Candida Detection