CALCITONIN IMMUNORADIOMETRIC ASSAY (IRMA) (COATED TUBE VERSION)
SCANTIBODIES LABORATORY, INC.
SCANTIBODIES LABORATORY, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 2020808 | 2020808 | SCANTIBODIES LABORATORY, INC. | 1 | N | 2026-01-01 | 9336 ABRAHAM WAY SANTEE CA US 92071 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 34106 | 1596053605 | K954247 | SYSCON CONTROL ASSAYED & UNASSAYED | JJY | 1996-02-14 |
| 34106 | 1547935982 | K944788 | INTACT PTH IMMUNORADIOMETRIC (IRMA) ASSAY (COATED BEAD-TECHNOLOGY) | CEW | 1995-07-19 |
| 34106 | 1928258423 | K060578 | CALCITONIN IMMUNORADIOMETRIC ASSAY (IRMA) (COATED TUBE VERSION) | JKR | 2006-08-30 |
| 34106 | 1643808008 | K051888 | TOTAL INTACT PTH IMMUNORADIOMETRIC ASSAY (COATED TUBE VERSION), MODEL 3KG013 | CEW | 2005-10-18 |
| 34106 | 1933775523 | K051810 | WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC ASSAY (IRMA) COATED TUBE KIT, MODEL 3KG014 | CEW | 2005-09-09 |
| 34106 | 1300557151 | K050748 | ACTH IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG011 | CKG | 2005-05-20 |
| 34106 | 1195517609 | K021032 | ACTH IMMUNORADIOMETRIC (IRMA) DIAGNOSTIC ASSAY KIT, MODEL #3KG100 | CKG | 2002-06-03 |
| 34106 | 1012059034 | K004038 | TOTAL PTH IMMUNORADIOMETRIC ASSAY(IRMA) DIAGNOSTIC KIT, MODEL 3KG600 | CEW | 2001-04-30 |
| 34106 | 1196245486 | ||||
| 34106 | 1223096295 | ||||
| 34106 | 1574525547 | ||||
| 34106 | 1837244601 | ||||
| 34106 | 1991098113 | ||||
| 34106 | 1991482472 |
Product Codes Associated With Registrations#
PMN#
MODIFICATION TO WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILLUMINOMETRIC (ICMA) ASSAY KIT, MODEL 3KG002
SCANTIBODIES LABORATORY, INC.
MODIFICATION TO: TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT
SCANTIBODIES LABORATORY, INC.
TOTAL INTACT PTH IMMUNORADIOMETRIC ASSAY (COATED TUBE VERSION), MODEL 3KG013
SCANTIBODIES LABORATORY, INC.
WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC ASSAY (IRMA) COATED TUBE KIT, MODEL 3KG014
SCANTIBODIES LABORATORY, INC.
TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT
SCANTIBODIES LABORATORY, INC.
WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILUMINOMETRIC ASSAY (ICMA), MODEL 3KG002
SCANTIBODIES LABORATORY, INC.
ACTH IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG011
SCANTIBODIES LABORATORY, INC.
CYCLASE ACTIVATING PTH (CAP) IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG001
SCANTIBODIES LABORATORY, INC.
ACTH IMMUNORADIOMETRIC (IRMA) DIAGNOSTIC ASSAY KIT, MODEL #3KG100
SCANTIBODIES LABORATORY, INC.
TOTAL PTH IMMUNORADIOMETRIC ASSAY(IRMA) DIAGNOSTIC KIT, MODEL 3KG600
SCANTIBODIES LABORATORY, INC.
WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC IRMA DIAGNOSTIC ASSAY KIT, MODEL 3KG056
SCANTIBODIES LABORATORY, INC.
SYSCOS IDC - G, IDC, BSC, IDC - G
SCANTIBODIES LABORATORY, INC.
SCANTIBODIES LABORATORY TSH IMMUNORADIOMETRIC ASSAY (IRMA)(COATED TUBE TECHNOLOGY)
SCANTIBODIES LABORATORY, INC.
SCANTIBODIES CALCITONIN IMMUNORADIOMETRIC ASSAY (COATED BEAD TECHNOLOGY)
SCANTIBODIES LABORATORY, INC.
SYSCON TURMOR MARKER CONTROL
SCANTIBODIES LABORATORY, INC.
SYSCON CONTROL ASSAYED & UNASSAYED
SCANTIBODIES LABORATORY, INC.
INTACT PTH IMMUNORADIOMETRIC (IRMA) ASSAY (COATED BEAD-TECHNOLOGY)
SCANTIBODIES LABORATORY, INC.
COLLEGE OF AMER PATH (CAP) SURV VALID PROST SPEC ANTI
SCANTIBODIES LABORATORY, INC.
GUDID#
Scantibodies Laboratory, Inc. - Whole PTH (1-84) Specific IRMA (Coated Bead)
2019-05-20
Scantibodies Laboratory, Inc. - Total Intact PTH IRMA (Coated Bead)
2019-05-20
Scantibodies Laboratory, Inc. - Total Intact PTH Assay IRMA (Coated Tube)
2019-05-20
Scantibodies Laboratory, Inc. - Calcitonin IRMA (Coated Tube)
2019-05-20
Scantibodies Laboratory, Inc. - ACTH (Adrenocorticotropic Hormone) IRMA (Coated Tube)
2019-05-20