FDA.reportPublic FDA data

Vitamin C (Ascorbic Acid)

Primary DI
00840239048882
Brand
Vitamin C (Ascorbic Acid)
Company
DRG International Inc
Model
ENZ-4888
Catalog number
ENZ-4888
Device description
This colorimetric microtiter plate assay is suitable for the determination of vitamin C (ascorbic acid) in Li-heparin plasma, serum and urine.
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
JMAAcid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JMAAcid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)Clinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840239048882PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840239048882008402390488828402390488820840239048882

GMDN Terms#

Term, Definition table
TermDefinition
Vitamin C (ascorbic acid) 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 vitamin C (ascorbic acid) in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
075150847
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
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
06935740751773Urine StripsUrit Medical Electronic Co., Ltd.JMA2026-06-03
06935740751780URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JMA2026-06-03
06935740751797URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JMA2026-06-03
06935740751803Urine StripsUrit Medical Electronic Co., Ltd.JMA2026-06-03
06935740751810Urine StripsUrit Medical Electronic Co., Ltd.JMA2026-06-03
06935740751827URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JMA2026-06-03
06935740751834Urine StripsUrit Medical Electronic Co., Ltd.JMA2026-06-03
06935740751841Urine AnalyzerUrit Medical Electronic Co., Ltd.JMA2026-06-03
06935740751858Urine AnalyzerUrit Medical Electronic Co., Ltd.JMA2026-06-03
06935740751865URINE ANALYZERUrit Medical Electronic Co., Ltd.JMA2026-06-03
06935740751872URINE ANALYZERUrit Medical Electronic Co., Ltd.JMA2026-06-03
06935740750608Urine Reagent StripsUrit Medical Electronic Co., Ltd.JMA2026-04-16
06935740750615Urine Reagent StripsUrit Medical Electronic Co., Ltd.JMA2026-04-16
06935740750738Automatic Urine AnalyzerUrit Medical Electronic Co., Ltd.JMA2026-04-16
10612479279886MckessonMCKESSON MEDICAL-SURGICAL INC.JMA2025-09-18
06935740733755Automatic Urine AnalyzerUrit Medical Electronic Co., Ltd.JMA2024-06-14
08806141303497One+Step 10ADFI CO.,LTDJMA2023-10-16
00657498002094Uri-Trak 120 M Urine AnalyzerSTANBIO LABORATORY, L.P.JMA2023-06-08
10884389181973MedlineMEDLINE INDUSTRIES, INC.JMA2022-04-13
10884389181959MedlineMEDLINE INDUSTRIES, INC.JMA2021-09-16
00722066005255Rapid ResponseBTNX IncJMA2020-12-14
04250317513854ReagentChromsystems Instruments + Chemicals GmbHJMA2020-08-27
04250317535801ReagentChromsystems Instruments + Chemicals GmbHJMA2020-08-27
04250317535979Reagent KitChromsystems Instruments + Chemicals GmbHJMA2020-08-27
04250317547460Reagent KitChromsystems Instruments + Chemicals GmbHJMA2020-08-27
04250317547477AccessorieChromsystems Instruments + Chemicals GmbHJMA2020-08-27
04250317547484AccessorieChromsystems Instruments + Chemicals GmbHJMA2020-08-27
04250317547491AccessorieChromsystems Instruments + Chemicals GmbHJMA2020-08-27
10888277110403MedlineMEDLINE INDUSTRIES, INC.JMA2020-08-21
10885380175589CARDINAL HEALTHCardinal Health 200, LLCJMA2020-07-09