FDA.reportPublic FDA data

IFA AMA Test System

Primary DI
00845533001410
Brand
IFA AMA Test System
Company
ZEUS SCIENTIFIC, INC.
Model
FA3001
Catalog number
FA3001
Device description
The ZEUS IFA Anti-Mitochondrial Antibody (AMA) Test System is designed for the qualitative and semi-quantitative detection of Mitochondrial Antibodies (MA) by the indirect fluorescent antibody (IFA) technique, 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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00845533001410PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845533001410008455330014108455330014100845533001410

GMDN Terms#

Term, Definition table
TermDefinition
Mitochondrial antibody M2 (anti-Mi2) 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 to mitochondria M2 (anti-Mi2) in a clinical specimen, using a fluorescent immunoassay method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
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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00845533002882Cardiac Muscle (Rat)5448RL5448RL2026-02-18
00845533002899Adrenal Cortex (Primate)6448L6448L2026-02-18
00845533002905Ovary (Primate)6648L6648L2026-02-18
00845533002912Testes (Primate)6748L6748L2026-02-18
00845533002929Mumps Virus IgGI-MUV01GI-MUV01G2026-02-18
00845533002936NTx UrineNTx90062026-02-18
00845533002943NTx SerumNTx9021NTx90212026-02-18
00845533002950Anti-Borrelia VlsE1/pepC10 IgG/IgMPF-SM3Z9661PF-SM3Z96612026-02-18
00845533002967ANA Screen2Z29001G2Z29001G2026-02-18
00845533002974ANA Screen SM2Z29001GSM2Z29001G2026-02-18
00845533002981ANCA Screen2Z9681G2Z9681G2026-02-18
00845533002998ANCA Screen SM2Z9681GSM2Z9681G2026-02-18
00845533003001Anti-Cardiolipin IgA2Z51051A2Z51051A2026-02-18