FDA.report

IMMCO DIAGNOSTICS

Primary DI
00845714002243
Brand
IMMCO DIAGNOSTICS
Company
IMMCO DIAGNOSTICS, INC.
Model
5127
Catalog number
5127
Device description
Sm Antibody ELISA
Published
2016-09-21
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
false

Related Records

Contact Domains

Product Codes

CodeName
LLLExtractable Antinuclear Antibody, Antigen And Control

Product Code Classifications

CodeDeviceSpecialtyClass
LLLExtractable Antinuclear Antibody, Antigen And ControlImmunology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00845714002243PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00845714002243008457140022438457140022430845714002243

GMDN Terms

TermDefinition
Smith antibody (anti-Sm) IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of anti-Smith (anti-Sm) antibodies in a clinical specimen, using an enzyme immunoassay (EIA) 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
00845714003363IMMCO DIAGNOSTICS219021902016-09-23
00845714003370IMMCO DIAGNOSTICS218921892016-09-23
00845714003387IMMCO DIAGNOSTICS218621862016-09-23
00845714003448IMMCO DIAGNOSTICS2167-82167-82016-09-23
00845714003462IMMCO DIAGNOSTICS250025002016-10-27
00845714003547IMMCO DIAGNOSTICS2152-102152-102016-09-23
00845714003554IMMCO DIAGNOSTICS215421542016-09-23

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B3507202600Gold Standard Diagnostics Is-anti-SS-B ELISA Test KitGold Standard Diagnostics CorporationLLL2022-12-05
B3507202700Gold Standard Diagnostics Is-anti-Sm/RNP ELISA Test KitGold Standard Diagnostics CorporationLLL2022-12-05
B3507202900Gold Standard Diagnostics Is-anti-Jo-1 ELISA Test KitGold Standard Diagnostics CorporationLLL2022-12-05
B3507202400Gold Standard Diagnostics Is-anti-Sm ELISA Test KitGold Standard Diagnostics CorporationLLL2022-12-03
B3507202800Gold Standard Diagnostics Is-anti-Scl-70 ELISA Test KitGOLD STANDARD DIAGNOSTICS CORP.LLL2020-07-27
07333066016108EliA SymphonyS WellPhadia ABLLL2020-06-30
05391516746854Trinity BiotechCLARK LABORATORIES, INC.LLL2019-12-27
05391516746762Trinity BiotechCLARK LABORATORIES, INC.LLL2019-12-26
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04048474035711ENA Screen ELISADRG Instruments Gesellschaft mit beschränkter HaftungLLL2019-06-10
00404847435719ENA Screen ELISADRG Instruments Gesellschaft mit beschränkter HaftungLLL2019-06-10
04250289502924AESKULISA® ENA-6S Aesku.Diagnostics GmbH & Co. KGLLL2017-02-28
04250289500449AESKULISA® ENA-6S Aesku.Diagnostics GmbH & Co. KGLLL2016-09-27
00816879020144Autostat II ENA-6 ScreenHYCOR BIOMEDICAL LLCLLL2016-09-26
00816879020298Autostat II Anti-SS-A/RoHYCOR BIOMEDICAL LLCLLL2016-09-26
00816879020304Autostat II Anti-SS-B/LaHYCOR BIOMEDICAL LLCLLL2016-09-26
00816879020335Autostat II Anti-Jo-1HYCOR BIOMEDICAL LLCLLL2016-09-26
00816879020342Autostat II Anti-Scl-70HYCOR BIOMEDICAL LLCLLL2016-09-26
00816879020380Autostat II Anti-ENA-6 ProfileHYCOR BIOMEDICAL LLCLLL2016-09-26
04049016027034Anti-SS-A ELISA (IgG)EUROIMMUN Medizinische Labordiagnostika AGLLL2016-09-24
04049016027041Anti-SS-B ELISA (IgG)EUROIMMUN Medizinische Labordiagnostika AGLLL2016-09-24
04049016027058Anti-Scl-70 ELISA (IgG)EUROIMMUN Medizinische Labordiagnostika AGLLL2016-09-24