FDA.reportPublic FDA data

Poly Rb a Hu Alpha-1-Antitrypsin

Primary DI
05700572000273
Brand
Poly Rb a Hu Alpha-1-Antitrypsin
Company
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
Model
A0012
Device description
Polyclonal Rabbit Anti-Human Alpha-1-Antitrypsin
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
DEWIGG, ANTIGEN, ANTISERUM, CONTROL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DEWIgg, Antigen, Antiserum, ControlImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K812495000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K812495000IMMUNOGL. FRCT. OF RABBIT ANTISER.-ALPHADako Corp.1981-09-23DEW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05700572000273PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05700572000273057005720002735700572000273

GMDN Terms#

Term, Definition table
TermDefinition
Alpha-1-antitrypsin (protease inhibitor) IVD, antibodyOne or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of alpha-1-antitrypsin (protease inhibitor) in a clinical specimen.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume2Milliliter

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4544859500dako.dkregulatory@agilent.com

Regulatory Flags#

DUNS number
894671143
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05700572005599Mono Mo A-Hu Prostatic Acid Phosphatase Cl PASE/4LJM07922020-09-17
05700572006305Mono Mo A-Cytokeratin 17 Cl E3M70462020-09-17
05700572018735Ig Reagent Rb F(ab')2/APCX09982020-09-17
05700572024613Mono Mo A-Hu CD22/APC Cl 4KB128C72812020-09-17
05700572024774Mono Mo a Hu CD61, Platelet Glycoprotein IIIa/APC, Cl Y2/51C72802020-09-17
05700572033929Mono Mo a Hu CD45R0/RPE, Cl UCHL1R08432020-09-17
05700572033936Mono Mo a Hu CD3/PB, Cl UCHT1PB9822020-09-17
05700572033950Mono Mo a Hu CD8/PB, Cl DK25PB9842020-09-17
05700572515258Mono Mo a Hu CD41, Platelet Glycoprotein IIb/RPE, Cl 5B12R70582020-09-17
05700572515432Mono Mo a Hu CD79ß/RPE, Cl SN8R72722020-09-17
05700572515715Mono Mo A-Hu CD7/FITC Cl DK24F07892020-09-17
05700572515746Mono Mo A-Hu CD25, Interleukin-2 Receptor/FITC Cl ACT-1F08012020-09-17
05700572516255Mono Mo a Hu CD5/RPE, Cl DK23R08422020-09-17
05700572516279Mono Mo a Hu CD14/RPE, Cl TÜK4R08642020-09-17
05700572516309Mono Mo a Hu CD16, Fc Gamma Receptor III/RPE, Cl DJ130cR70122020-09-17
05700572516316Mono Mo a Hu CD20/RPE, Cl B-Ly1R70132020-09-17
05700572516347Mono Mo a Hu CD45RA/RPE, Cl 4KB5R70862020-09-17
05700572516361Mono Mo a Hu CD34 Class III/RPE, Cl BIRMA-K3R71252020-09-17
05700572516378Mono Mo a Hu CD38/RPE, Cl AT13/5R71442020-09-17
05700572516408Mono Mo a Hu CD103, Mucosa Lymphocyte Antigen/RPE, Cl Ber-ACT8R71882020-09-17

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00380740169893AlinityABBOTT IRELANDDEW2021-04-29
00380740169909ARCHITECTABBOTT IRELANDDEW2021-04-02
00380740175184ARCHITECTAbbott GmbHDEW2020-11-06
00630414002903BN II SystemSiemens Healthcare Diagnostics Products GmbHDEW2020-09-24
03610230007358Yumizen C1200 Immunoglobulin GHORIBA ABX SASDEW2020-07-13
07613336121320Tina-quant IgG Gen.2Roche Diagnostics GmbHDEW2020-03-05
00380740153922AlinityAbbott GmbHDEW2019-12-24
03573026619527VIDAS® PC SOFTWARE V4.9BIOMERIEUX SADEW2019-12-20
05055273203967IgGRANDOX LABORATORIES LIMITEDDEW2019-06-03
00842768012167N Cuvette Segments for BN IISiemens Healthcare Diagnostics Products GmbHDEW2017-11-15
00842768012174N Predilution WellsSiemens Healthcare Diagnostics Products GmbHDEW2017-10-31
B1761010Antiserum to Human IgG (gamma chain specific)KENT LABORATORIES INCDEW2016-09-24
05051700010368Human IgG, IgA, IgM ‘NL’ BINDARID™ COMBI RID KitTHE BINDING SITE GROUP LIMITEDDEW2016-09-24
05051700010399Human IgG Subclass Single Dilution BINDARID™ Kit - Bulk KitTHE BINDING SITE GROUP LIMITEDDEW2016-09-24
05051700010443Human IgG - ‘NL’ BINDARID™ Radial Immunodiffusion Kit THE BINDING SITE GROUP LIMITEDDEW2016-09-24
05051700010917Human IgG1 Subclass Single Dilution BINDARID™ KitsTHE BINDING SITE GROUP LIMITEDDEW2016-09-24
05051700010924Human IgG2 Subclass Single Dilution BINDARID™ KitsTHE BINDING SITE GROUP LIMITEDDEW2016-09-24
05051700010931Human IgG3 Subclass Single Dilution BINDARID™ KitsTHE BINDING SITE GROUP LIMITEDDEW2016-09-24
05051700010948Human IgG3 Subclass Single Dilution BINDARID™ KitsTHE BINDING SITE GROUP LIMITEDDEW2016-09-24
05055273203936IgGRANDOX LABORATORIES LIMITEDDEW2016-09-24
05055273203950IgGRANDOX LABORATORIES LIMITEDDEW2016-09-24
05055273203974IgGRANDOX LABORATORIES LIMITEDDEW2016-09-24
00840733101304MERIFLUOR GullSORB MERIDIAN BIOSCIENCE, INC.DEW2016-09-23
04015630913923IGG Immunoglobulin G Turbidimetric)Roche Diagnostics GmbHDEW2016-09-20
04015630919697Tinaquant IgG Gen2Roche Diagnostics GmbHDEW2016-09-20
04015630919710Tinaquant IgG Gen2Roche Diagnostics GmbHDEW2016-09-20
04015630925735Tinaquant IgG Gen2Roche Diagnostics GmbHDEW2016-09-20
05700572000860Poly Rb A-Hu IgA, IgG, IgMAGILENT TECHNOLOGIES SINGAPORE PTE LTDDEW2016-09-16
05700572001386Poly Rb A-Hu IgGAGILENT TECHNOLOGIES SINGAPORE PTE LTDDEW2016-09-16
00816426020108K-ASSAY® IgG ReagentKAMIYA BIOMEDICAL COMPANY, LLCDEW2016-09-16