FDA.reportPublic FDA data

Scantibodies Laboratory, Inc.

Primary DI
00850002253160
Brand
Scantibodies Laboratory, Inc.
Company
SCANTIBODIES LABORATORY, INC.
Model
3KG011
Device description
ACTH (Adrenocorticotropic Hormone) IRMA (Coated Tube)
Published
2019-05-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
CKGRadioimmunoassay, Acth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CKGRadioimmunoassay, ActhClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K050748000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K050748000ACTH IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG011Scantibodies Laboratory, Inc.2005-05-20CKG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850002253160PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850002253160008500022531608500022531600850002253160

GMDN Terms#

Term, Definition table
TermDefinition
Adrenocorticotropic hormone (ACTH) IVD, kit, radioimmunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of the adrenocorticotropic hormone (ACTH) in a clinical specimen, using a radioimmunoassay method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
087577680
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850002253115Scantibodies Laboratory, Inc.3KG0562019-05-20
00850002253122Scantibodies Laboratory, Inc.3KG6002019-05-20
00850002253139Scantibodies Laboratory, Inc.3KG0132019-05-20
00850002253153Scantibodies Laboratory, Inc.3KG5562019-05-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816870023847ACTH AccuBind ELISA Test System - 96 WellsMONOBIND, INC.CKG2024-09-13
00816870024806ACTH AccuBind ELISA Test System - 192 WellsMONOBIND, INC.CKG2024-09-13
00816870024844ACTH AccuLite CLIA Test System - 192 WellsMONOBIND, INC.CKG2024-09-13
04048474036473ACTH (Adrenocorticotropic Hormone) ELISADRG Instruments Gesellschaft mit beschränkter HaftungCKG2023-08-31
05060169696457IDS ACTH IIIMMUNODIAGNOSTIC SYSTEMS LIMITEDCKG2023-08-23
00083059070231ACTH [Adrenocorticotropic Hormone] ELISABIOMERICA, INC.CKG2020-07-01
00840239036476ACTH (Adrenocorticotropic Hormone) ELISADRG International IncCKG2019-03-20
B24221ACTHUE010Adrenocorticotropic Hormone ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.CKG2017-08-03
04015630939893Elecsys ACTHRoche Diagnostics GmbHCKG2017-04-21
08305900070231ACTH [Adrenocorticotropic Hormone] ELISABIOMERICA, INC.CKG2016-12-07
00817830022276ImmuChem hACTH Double Antibody 125I RIA KitMP BIOMEDICALS, LLCCKG2016-10-20
00817830022283ImmuChem hACTH Double Antibody 125I RIA KitMP BIOMEDICALS, LLCCKG2016-10-20
14560189212517ST AIA-PACK ACTHTOSOH CORPORATIONCKG2016-09-24
04560189212541AIA-PACK ACTH Sample Diluting SolutionTOSOH CORPORATIONCKG2016-09-24
00630414953502IMMULITE®/IMMULITE® 1000 Systems ACT ACTH Sample DiluentSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCKG2016-09-24
00630414960999IMMULITE® 2000 Systems ACT ACTHSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCKG2016-09-24
00630414963532IMMULITE®/IMMULITE® 1000 Systems ACT ACTHSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCKG2016-09-24
04015630921522Elecsys ACTH Test SystemRoche Diagnostics GmbHCKG2016-09-20