FDA.report

IMMCO DIAGNOSTICS

Primary DI
00845714000577
Brand
IMMCO DIAGNOSTICS
Company
IMMCO DIAGNOSTICS, INC.
Model
1140-250
Catalog number
1140-250
Device description
Anti-neutrophil Cytoplasmic Antibody (ANCA) IFA Kit
Published
2016-09-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
MOBTest System, Antineutrophil Cytoplasmic Antibodies (Anca)

Product Code Classifications

CodeDeviceSpecialtyClass
MOBTest System, Antineutrophil Cytoplasmic Antibodies (Anca)Immunology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00845714000577PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00845714000577008457140005778457140005770845714000577

GMDN Terms

TermDefinition
Multiple anti-neutrophil cytoplasmic antibody (ANCA) 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 anti-neutrophil cytoplasmic antibodies (ANCA) in a clinical specimen, using a fluorescent immunoassay method.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
1-800-537-8378INFO@IMMCO.COM

Regulatory Flags

DUNS number
079935300
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
true
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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00845714001024IMMCO DIAGNOSTICS1107-1X1107-1X2016-09-21
00845714001994IMMCO DIAGNOSTICS2152-32152-32016-09-23
00845714003332IMMCO DIAGNOSTICS219121912016-09-23
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00845714003387IMMCO DIAGNOSTICS218621862016-09-23
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00845714003462IMMCO DIAGNOSTICS250025002016-10-27
00845714003547IMMCO DIAGNOSTICS2152-102152-102016-09-23
00845714003554IMMCO DIAGNOSTICS215421542016-09-23

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