FDA.reportPublic FDA data

ACTH (Adrenocorticotropic Hormone) ELISA

Primary DI
00840239036476
Brand
ACTH (Adrenocorticotropic Hormone) ELISA
Company
DRG International Inc
Model
EIA-3647
Catalog number
EIA-3647
Device description
The DRG ACTH ELISA is intended for the quantitative determination of ACTH (Adreno-corticotropic Hormone) in human plasma.
Published
2019-03-20
Public version status
Update
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
00840239036476PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840239036476008402390364768402390364760840239036476

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Total Volume2Milliliter
Total Volume2.7Milliliter
Total Volume4Milliliter
Total Volume15.5Milliliter
Total Volume20Milliliter
Total Volume30Milliliter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(973)564-7555corp@drg-international.com

Regulatory Flags#

DUNS number
075150847
Device count
1
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840239041173ANA Detect ELISAEIA-4117EIA-41172023-08-25
00840239035622ANA-8-Screen ELISAEIA-3562EIA-35622023-08-24
00840239035639ANA-8-Profile ELISAEIA-3563EIA-35632023-08-24
00840239027733ANA Screen IgG ELISA EIA-2773EIA-27732023-08-23
00840239035899Anti-Cardiolipin Screen ELISAEIA-3589EIA-35892023-08-25
00840239035967c-ANCA (PR3) ELISAEIA-3596EIA-35962023-08-25
00840239036025Anti-Lactoferrin ELISAEIA-3602EIA-36022023-08-25
00840239059673Measles Virus IgG Avidity ELISAEIA-5967EIA-59672023-08-26
00840239060594Giardia/Cryptosporidium Ag (stool) ELISA EIA-6059EIA-60592023-08-26
00840239027931Epstein Barr Virus VCA IgG ELISAEIA-2793EIA-27932023-08-24
00840239027948Epstein Barr Virus VCA IgM ELISAEIA-2794EIA-27942023-08-24
00840239027962EBV-EA IgG ELISAEIA-2796EIA-27962023-08-24
00840239028150H. Pylori IgG ELISA EIA-2815EIA-28152023-08-24
00840239033710Gliadin IgG ELISA EIA-3371EIA-33712023-08-24
00840239034670Cryptosporidium Antigen (stool) ELISA EIA-3467EIA-34672023-08-24
00840239034731Entamoeba histolytica Ag (stool) ELISA EIA-3473EIA-34732023-08-24
00840239034779Giardia lamblia Antigen (stool) ELISA EIA-3477EIA-34772023-08-24
00840239035523HGH (Human Growth Hormone) ELISAEIA-3552EIA-35522023-08-24
00840239035615Anti TPO Ab ELISAEIA-3561EIA-35612023-08-24
00840239035646Anti-dsDNA IgM ELISAEIA-3564EIA-35642023-08-24

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