FDA.report

IFA AAS Mouse Kidney/Stomach/Liver Test System

Primary DI
00845533001441
Brand
IFA AAS Mouse Kidney/Stomach/Liver Test System
Company
ZEUS SCIENTIFIC, INC.
Model
FA3403
Catalog number
FA3403
Device description
The ZEUS IFA Autoantibody Screen (AAS) Mouse Kidney/Stomach/Liver Tissue Test System is designed for the qualitative and semi-quantitative detection of antinuclear, mitochondrial, smooth muscle and parietal cell antibodies by the indirect fluorescent antibody IFA technique. It aids in determining SLE and differentiating clinically similar connective tissue disorders, and is for In Vitro diagnostic use.
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00845533001441PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00845533001441008455330014418455330014410845533001441

GMDN Terms

TermDefinition
Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, kit, fluorescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple antibodies associated with systemic lupus erythematosus (SLE) in a clinical specimen, using an fluorescent immunoassay method.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
080953946
Device count
1
DM exempt
false
Premarket exempt
false
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

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