FDA.reportPublic FDA data

Micro-Albumin ELISA

Primary DI
00840239038814
Brand
Micro-Albumin ELISA
Company
DRG International Inc
Model
EIA-3881
Catalog number
EIA-3881
Device description
Micro-Albumin ELISA is a competitive test system for the quantitative measurement of human albumin in urine.
Published
2019-03-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
JIRINDICATOR METHOD, PROTEIN OR ALBUMIN (URINARY, NON-QUANT.)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JIRIndicator Method, Protein Or Albumin (Urinary, Non-Quant.)Clinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K970932000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K970932000ORGENTEC MICRO-ALBUMIN EIA ASSAYAmerican Laboratory Products Co., Ltd.1997-04-08JIR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840239038814PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840239038814008402390388148402390388140840239038814

GMDN Terms#

Term, Definition table
TermDefinition
Microalbumin IVD, kit, enzyme spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of microalbumin in a clinical specimen, using an enzyme spectrophotometry 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
Total Volume0.5Milliliter
Total Volume15Milliliter
Total Volume20Milliliter

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
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00840239027733ANA Screen IgG ELISA EIA-2773EIA-27732023-08-23
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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
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00840239028150H. Pylori IgG ELISA EIA-2815EIA-28152023-08-24
00840239033710Gliadin IgG ELISA EIA-3371EIA-33712023-08-24
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00840239034731Entamoeba histolytica Ag (stool) ELISA EIA-3473EIA-34732023-08-24
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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

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