FDA.reportPublic FDA data

Histamine ELISA

Primary DI
04048474058277
Brand
Histamine ELISA
Company
DRG Instruments Gesellschaft mit beschränkter Haftung
Model
EIA-5827
Catalog number
EIA-5827
Device description
The Quantitative Determination of Total Thyroxine Concentration in Human Serum or Plasma by a Microplate Enzyme Immunoassay
Published
2023-09-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IAFWright'S Stain

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IAFWright'S StainHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048474058277PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048474058277040484740582774048474058277

GMDN Terms#

Term, Definition table
TermDefinition
Multiple biogenic amine neurotransmitter IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of multiple biogenic amine neurotransmitters [e.g., catecholamines (dopamine, norepinephrine, epinephrine), histamine, serotonin] and/or multiple biogenic amine neurotransmitter intermediate metabolites (e.g., metanephrine, normetanephrine, 3-methoxytyramine) in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
973-564-7555corp@drg-international.com

Regulatory Flags#

DUNS number
317134468
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04048474041170ANA Detect ELISAEIA-4117EIA-41172023-08-31
04048474027730ANA Screen IgG ELISA EIA-2773EIA-27732023-08-29
04048474035629ANA-8-Screen ELISAEIA-3562EIA-35622019-06-05
04048474035636ANA Combi (ANA-8-Profile) ELISAEIA-3563EIA-35632019-06-10
04048474018646TGF-Beta 1 ELISAEIA-1864EIA-18642024-11-22
04048474059670Measles Virus IgG Avidity ELISAEIA-5967EIA-59672023-09-01
04048474060591Giardia/Cryptosporidium Ag (stool) ELISA EIA-6059EIA-60592023-09-01
04048474027747DNA (ds) IgG ELISAEIA-2774EIA-27742023-08-29
04048474027938Epstein Barr Virus VCA IgG ELISAEIA-2793EIA-27932023-08-29
04048474027945Epstein Barr Virus VCA IgM ELISAEIA-2794EIA-27942023-08-29
04048474027969EBV-EA IgG ELISAEIA-2796EIA-27962023-08-29
04048474028157H. Pylori IgG ELISA EIA-2815EIA-28152023-08-29
04048474033717Gliadin IgG ELISA EIA-3371EIA-33712023-08-29
04048474034448Adenovirus Antigen (stool) ELISA EIA-3444EIA-34442023-08-29
04048474034677Cryptosporidium Antigen (stool) ELISA EIA-3467EIA-34672023-08-29
04048474034738Entamoeba histolytica Ag (stool) ELISA EIA-3473EIA-34732023-08-29
04048474034776Giardia lamblia Antigen (stool) ELISA EIA-3477EIA-34772023-08-29
04048474036022Anti-Lactoferrin ELISAEIA-3602EIA-36022023-08-29
04048474035520hGH ELISAEIA-3552EIA-35522019-06-10
04048474035612Anti TPO Ab ELISAEIA-3561EIA-35612019-06-10

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Primary DI, Brand, Company table
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00630414323619Atellica HEMA SMS M-W BufferSiemens Healthcare Diagnostics Inc.IAF2026-02-06
00630414323633Atellica HEMA SMS M-W StainSiemens Healthcare Diagnostics Inc.IAF2026-02-06
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00860011780526Chemical Service Labs, LLCProtean Resources, LLC.IAF2024-03-18
00840239058270Histamine ELISA DRG International IncIAF2023-08-26
07290016650617QwikCheck DFI KitM.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.IAF2023-06-08
14719874741591LensHooke Sperm DNA fragmentation test kit (SCD assay)BONRAYBIO CO., LTD.IAF2021-11-18
00630414473499Hematek® Stain Pak - Modified Wright's StainSiemens Healthcare Diagnostics Inc.IAF2020-09-24
00630414503936ADVIA® Autoslide Modified Wright's StainSiemens Healthcare Diagnostics Inc.IAF2020-09-24
00630414503967ADVIA® Autoslide Modified Wright's BufferSiemens Healthcare Diagnostics Inc.IAF2020-09-24
10885380152283CARDINAL HEALTHCardinal Health 200, LLCIAF2018-01-30