FDA.reportPublic FDA data

H.PYLORI

Primary DI
00810119676252
Brand
H.PYLORI
Company
BIOGENEX LABORATORIES
Model
AM880-10M
Catalog number
AM880-10M
Published
2023-05-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
MVUReagents, Specific, Analyte

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MVUReagents, Specific, AnalytePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810119676252PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810119676252008101196762528101196762520810119676252

GMDN Terms#

Term, Definition table
TermDefinition
Multiple gastrointestinal disease marker IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of one or multiple antigens or markers associated with gastrointestinal disease in a clinical specimen. These markers may include pepsinogen I, pepsinogen II, gastrin and/or antibodies to the bacteria Helicobacter pylori.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume10Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at 2-8°C

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 (800) 421-4149support@biogenex.com

Regulatory Flags#

DUNS number
042697045
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810119676733ANTI-HER2/ERBB2AY726-YCDAY726-YCD2023-05-04
00810119679062ANTI-C-ERBB-2NU753-UCNU753-UC2023-04-25
00810119677433Anti- HER2/ERBB2 PHOSPHO (PY877)NU726-UCNU726-UC2023-04-21
00810119676443ANTI-HER2/ERBB2AN726-5MAN726-5M2023-04-20
00810119674395ANTI- HER2/ERBB2NU726-5UCNU726-5UC2023-04-19
00810119674562ANTI-C-ERBB-2 (HER-2/NEU)MU134-5UCMU134-5UC2023-04-19
00810119674890ANTI- HER2/ERBB2NU726-UCNU726-UC2023-04-19
00810119673541ANTI-C-ERBB-2 (HER-2/NEU)MU134-5UCMU134-5UC2023-04-18
00810119671363ANTI-C-ERBB-2 (HER-2/NEU)AM134-5MAM134-5M2023-04-03
00810119674876ANTI-C-ERBB-2 (HER-2/NEU)MU134-UCMU134-UC2023-03-29
00810119670069ANTI-HER2/ERBB2AN726-5MAN726-5M2023-03-28
00810119670373ANTI-C-ERBB-2 (HER-2/NEU)AM134-5MAM134-5M2023-03-28
00810119670168ANTI-HER2/ERBB2AN726-10MAN726-10M2023-03-27
00810119673923ANTI-VIPAR530-5RAR530-5R2023-05-12
00810119678713ANTI-VIPPU530-UPPU530-UP2023-04-24
00810119673169ANTI-TAUAM412-5MAM412-5M2023-04-17
00810119672513ANTI-TAUAM459-5MAM459-5M2023-04-06
00810119671202ANTI-BETA-HCGAM395-5MAM395-5M2023-03-31
00810119673411TRIS WASH BUFFERHK098-5KHK098-5K2023-05-12
00850646007341DiluentHK156-5KEHK156-5KE2023-05-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810034704481PE anti-human CD366BIOLEGEND, INC.MVU2026-09-04
00810034703170PerCP anti-human CD61BIOLEGEND, INC.MVU2026-08-07
03661540953170DSQ Alert HT Adenovirus Primer Mix ASRElitechgroup Mdx LLCMVU2026-08-07
03661540953187DSQ Alert HT Adenovirus Probe Mix ASRElitechgroup Mdx LLCMVU2026-08-07
03661540953217DSQ Alert Hepatitis E Primer Mix ASRElitechgroup Mdx LLCMVU2026-08-07
03661540953224DSQ Alert Hepatitis E Probe Mix ASRElitechgroup Mdx LLCMVU2026-08-07
03661540953279DSQ Alert Mycoplasma pneumoniae Primer Mix ASRElitechgroup Mdx LLCMVU2026-08-07
03661540953286DSQ Alert Mycoplasma pneumoniae Probe Mix ASRElitechgroup Mdx LLCMVU2026-08-07
00810034704252FITC anti-human TNF-AlphaBIOLEGEND, INC.MVU2026-07-28
00810034704320PE anti-human IL-2BIOLEGEND, INC.MVU2026-07-28
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00810227730051Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-21
00810227730068Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-21
00810227730136Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-21
00810227730143Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-21
00810227730150Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-21