FDA.reportPublic FDA data

N/A

Primary DI
00850041798028
Brand
N/A
Company
Key Scientific Products Incorporated
Model
K982375
Device description
PEP REAGENT
Published
2023-09-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850041798028PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850041798028008500417980288500417980280850041798028

GMDN Terms#

Term, Definition table
TermDefinition
Indole/Kovac's microbial reagent IVDA substance or reactant, sometimes referred to as indole reagent or Kovac's reagent, intended to be used in the testing of a microorganism isolated from a clinical specimen by culture, to detect the presence of enzymes that split indole from the amino acid tryptophan.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store between 2 and 8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
783601115
Device count
1
DM exempt
true
Kit
true
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850041798059N/AKS70WH502023-12-18
00850041798042N/AK9823752023-10-25
00850041798011N/AKF40122023-09-08
00850041798035N/AK1538B2023-09-07
00850041798004N/AK1538B2023-09-05