Scantibodies Laboratory, Inc.

GUDID 00850002253122

Total Intact PTH IRMA (Coated Bead)

SCANTIBODIES LABORATORY, INC.

Parathyroid hormone (PTH) IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 00850002253122
• NIH Device Record Key: 49aeb4f6-2a0b-4347-ad22-56c65faf893d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Scantibodies Laboratory, Inc.
• Version Model Number: 3KG600
• Company DUNS: 087577680
• Company Name: SCANTIBODIES LABORATORY, 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: false
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850002253122 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K004038

FDA Product Code

• CEW: Radioimmunoassay, Parathyroid Hormone

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: 2019-12-23
• Device Publish Date: 2019-05-20

On-Brand Devices [Scantibodies Laboratory, Inc.]

• 00850002253160: ACTH (Adrenocorticotropic Hormone) IRMA (Coated Tube)
• 00850002253153: Calcitonin IRMA (Coated Tube)
• 00850002253139: Total Intact PTH Assay IRMA (Coated Tube)
• 00850002253122: Total Intact PTH IRMA (Coated Bead)
• 00850002253115: Whole PTH (1-84) Specific IRMA (Coated Bead)