FDA.reportPublic FDA data

ACTH [Adrenocorticotropic Hormone] ELISA

Primary DI
00083059070231
Brand
ACTH [Adrenocorticotropic Hormone] ELISA
Company
BIOMERICA, INC.
Model
7023
Device description
The Biomerica ACTH ELISA is intended for the quantitative determination of ACTH (Adrenocorticotropic Hormone) in human plasma. This assay is intended for in vitro diagnostic use.
Published
2020-07-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
K982608000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K982608000SANGUI BIOTECH, INC. ACTH (ADRENOCORTICOTROPIC HORMONE) ELISA KITSangui Biotech, Inc.1998-08-19CKG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00083059070231PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00083059070231000830590702310830590702310083059070231

GMDN Terms#

Term, Definition table
TermDefinition
Adrenocorticotropic hormone (ACTH) IVD, kit, enzyme immunoassay (EIA)A 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 an enzyme immunoassay (EIA) method.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 949 645 2111info@biomerica.com

Regulatory Flags#

DUNS number
067647321
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

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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
00850002253160Scantibodies Laboratory, Inc.SCANTIBODIES LABORATORY, INC.CKG2019-05-20
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