FDA.reportPublic FDA data

Hackberry, Celtis occidentalis

Primary DI
00816879020878
Brand
Hackberry, Celtis occidentalis
Company
HYCOR BIOMEDICAL LLC
Model
T44
Catalog number
749700
Published
2020-08-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

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
00816879020878PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816879020878008168790208788168790208780816879020878

GMDN Terms#

Term, Definition table
TermDefinition
Assay development analyte-specific reagent IVDAn antibody, specific receptor protein, ligand, nucleic acid sequence (e.g., primer, probe) or similar reagent, which through specific binding or chemical reaction with an intended target, is used to identify or quantify a chemical substance in a biological specimen for the development of a laboratory developed test (LDT) or commercial in vitro diagnostic medical device (IVD). Commonly referred to as an analyte specific reagent (ASR), it is neither labelled with instructions for use nor diagnostic or performance claims.

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
800-382-2527Customerservices-us@hycorbiomedical.com

Regulatory Flags#

DUNS number
010558476
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810053950098NOVEOS Peanut, Arachis hypogaeaF01363229Z2026-01-22
00810053950272NOVEOS Bos d 4 α-lactalbumin, MilkF076C63248Z2026-01-22
00810053950289NOVEOS Bos d 5 b-lactoglobulin, MilkF077C63249-3Z2026-01-22
00810053950388NOVEOS Gal d 2 Ovalbumin, EggF232C63265Z2026-01-22
00816879023565NOVEOS Peanut, Arachis hypogaeaF013632292026-01-22
00816879023831NOVEOS Bos d 4 α-lactalbumin, MilkF076C632482026-01-22
00816879023909NOVEOS Gal d 2 Ovalbumin, EggF232C632652026-01-22
00816879024685NOVEOS Bos d 5 b-lactoglobulin, MilkF077C63249-32026-01-22
00810053950159NOVEOS Shrimp, Shrimp spp. Pleoticus muelleri, Panaeus monodonF0248632350Z2026-01-20
00810053950371NOVEOS Clam, Mercenaria mercenariaF2078633560Z2026-01-20
00810053950401NOVEOS Walnut, Juglans spp. Juglans regia, Juglans nigraF2568632680Z2026-01-20
00810053950500NOVEOS German Cockroach, Blatella germanicaI0068632950Z2026-01-20
00816879023800NOVEOS Shrimp, Shrimp spp. Pleoticus muelleri, Panaeus monodonF02486323502026-01-20
00816879024463NOVEOS German Cockroach, Blatella germanicaI00686329502026-01-20
00816879024555NOVEOS Clam, Mercenaria mercenariaF20786335602026-01-20
00816879028010NOVEOS Walnut, Juglans spp. Juglans regia, Juglans nigraF25686326802026-01-20
00810053950586NOVEOS Mulberry, Morus albaT0708633250Z2025-08-27
00816879024500NOVEOS Mulberry, Morus albaT07086332502025-08-27
00810053950623NOVEOS Lamb's Quarters, Goosefoot, Chenopodium albumW0108633340Z2025-08-25
00816879024159NOVEOS Lamb’s Quarters, Goosefoot, Chenopodium albumW01086333402025-08-25

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03661540953132DSQ Alert RNase P Primer Mix ASR 48 rxnElitechgroup Mdx LLCMVU2026-03-24
03661540953163DSQ Alert RNase P Probe Mix ASR 48 rxnElitechgroup Mdx LLCMVU2026-03-24
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