FDA.reportPublic FDA data

Vitamin C (Ascorbic Acid)

Primary DI
00404847448887
Brand
Vitamin C (Ascorbic Acid)
Company
DRG Instruments Gesellschaft mit beschränkter Haftung
Model
N/A
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
2019-06-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
00404847448887PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00404847448887004048474488874048474488870404847448887

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 Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
317134468
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
00840239048882Vitamin C (Ascorbic Acid)DRG International IncJMA2023-09-01
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
10673486000672TECO DIAGNOSTICSTECO DIAGNOSTICSJMA2020-03-09
00722066001219Rapid ResponseBTNX IncJMA2019-10-16
06945040104780CONTECContec Medical Systems Co., Ltd.JMA2019-09-10
04048474048889Vitamin C (Ascorbic Acid)DRG Instruments Gesellschaft mit beschränkter HaftungJMA2019-06-10
08806141301479QTEST™ 11DFI CO.,LTDJMA2018-12-21
10722355002917Detector UA 2GPImmunostics Company, IncJMA2018-11-20
10722355002924Detector UA 10SGImmunostics Company, IncJMA2018-11-20
08806125680279UCARE 11 StickYD Diagnostics CORP.JMA2017-07-28
08806125680286UCARE 11 StickYD Diagnostics CORP.JMA2017-07-28
10612479183466McKessonMCKESSON MEDICAL-SURGICAL INC.JMA2016-12-09